Quality Control Associate jobs in United States, Pennsylvania, East Bradford Township

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

• Provide strategic leadership and oversight to ensure regulatory compliance across the product lifecycle.
• Manage highly complex regulatory projects, including drug-device combination products.
• Drive pre-market and post-market regulatory initiatives for successful product commercialization and compliance.
• Collaborate with internal teams such as Research and Development, Clinical, QA, Operations, Commercial, Legal, and Finance to execute key projects.
• Manage and support regulatory personnel in accordance with West and government requirements.
• Assist with US, EU, and ROW clinical programs and regulatory approvals.
• Enhance cross-functional effectiveness and drive continuous improvement in regulatory and quality operations.
• Maintain an up-to-date understanding of health authority guidelines and regulations to shape future regulatory strategies.

• Bachelor's Degree In science, math, engineering, or related discipline required
• Master's Degree In science, math, engineering, or related discipline preferred
• PhD In science, math, engineering, or related discipline preferred

• Bachelor’s Degree with 10+ years; Master’s Degree/PhD 5-8 years regulatory/pharmaceutical experience required
• Experience directly interacting and presenting to project teams, customers, industry groups required

• Able to work collaboratively across all levels of the organization to influence and persuade others.
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Excellent interpersonal, communication and listening skills.
• Knowledge of regulatory guidance documents and standards related to human factors, combination products, delivery system and design controls.
• Experience in medical device regulatory affairs and/or design control process, direct interactions with regulatory agencies and management of regulatory support systems.
• Regulatory compliance competency including Quality Systems
• International regulatory competency
• Advanced degree

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions. Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

Conducting Investigations:

• Investigate a wide range of issues, including harassment, discrimination, retaliation, ethics violations, and policy breaches.
• Gather evidence by interviewing complainants, witnesses, and others involved.
• Review relevant documents and policies to establish facts and determine outcomes.

Reporting and Analysis:

• Prepare comprehensive, factual, and well-documented investigation reports with findings and recommendations for action.
• Maintain accurate and confidential records of all investigative activities and case tracking.
• Analyze case data to identify trends, inform policy updates, and develop proactive strategies.

Auditing and Compliance:

• Conducts audits on site compliance to HR Policy as well as Employee Culture.
• Conduct regular audits of employee relations cases and documentation to ensure adherence to established procedures and legal requirements.
• Stay up-to-date on federal, state, and local employment laws and best practices.

Consultation and Guidance:

• Provide expert advice and consultation to HR, managers, and leaders on employee relations matters and appropriate disciplinary actions.
• Partner with Legal and Compliance departments to ensure consistent and appropriate handling of cases.

Process Improvement:

• Proactively identify opportunities to improve Employee Relations processes, policies, and tools.
• Develop and facilitate training for employees and managers on employee relations topics and conflict resolution.

Bachelor's degree in Human Resources or a related field and/ or five years of directly related experience, or equivalent experience.

• Minimum of 5 years of relevant experience Human Resources.

• Exceptional strategic thinking, problem-solving, and organizational skills.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate with senior leadership and legal counsel.

The Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch. Primary responsibilities center on being able to develop, implement and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities related to the management of CGMP analytical method lifecycle (e.g. management of reference standard, assay control, critical reagents and materials, product specification and sampling plan processes). The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position.

Overseeing QC laboratory operations by managing a team of professionals and junior managers who execute physiochemical CGMP testing.
Establishing and maintaining strategies for method and/or process implementation, continuous improvement initiatives, and method transfer and validation processes.
Developing strategies and approaches for special studies, as applicable.
Ensuring compliance with applicable ICH, GxP and safety regulations as an individual contributor as well as an educator and manager of junior staff. Executional tasks include but are not limited to:
• Supporting general GxP and data integrity compliance in both routine and non-routine work activities for both internal and external contract lab testing. This includes efforts as an individual contributor that may include but are not limited to the review and approval of data in raw and reported forms as well as training staff in compliance or technical principles
• Providing oversight and/or support of QC lab investigations, audits, inspections, and communications with regulatory agencies and health authorities
• Providing support for staff who identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols, and reports. Executing these tasks as an individual contributor, as applicable
Engaging, coaching, motivating and empowering staff to ensure their skills match their roles and to continually develop, thereby improving productivity and efficiency of the department operations.

Education
Minimum: BS/MS in relevant discipline
Preferred: PhD in Biochemistry, Analytical Chemistry

Experience
10-15+ years (BS/MS/PhD) in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing applications and one or more areas of drug development

Specialized Knowledge:
LIMS, TrackWise or VEEVA Quality Management Systems, Documentum Based Systems

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Important notice to Employment Agencies - Please Read Carefully

The Associate Director of Transparency and Disclosure (T&D) is responsible for leading and managing global Transparency & Disclosure activities. This role will serve as a subject matter expert and will manage the processes and procedures to ensure compliance with global regulatory requirements. The Associate Director will partner with and lead interactions with senior management in relevant functional areas and manage staff who are directly involved in activities related to disclosure and transparency. Oversight of staff who manage clinical trial registry activities, lay language results summaries, and data sharing requests will also be in scope.

• Ensures compliance with US/EU requirements for clinical data transparency and disclosure, including EMA Policy 0070, EMA Policy 0043 and Health Canada.
• Ensure development of plain language results summaries.
• Manages and oversees vendor/CRO involvement for registrations, results postings, and plain language summaries to assure data harmonization.
• Oversees facilitation of registration and results postings in Teva’s clinical trial disclosure platform for global data harmonization management.
• Oversee internal systems experts, including but not limited to disclosure and document management databases.
• Assures quality and accuracy with clinical trial information in public registries.
• Facilitates review and assessment of data sharing requests from external researchers.
• Ensures maintenance of transparency, including routine updates of active registrations and updates to results disclosures.
• Establishes and maintains close working relationships with project teams, as well as with other internal stakeholders.
• Works cross-functionally to continuously improve processes and facilitates SOP updates.
• Internal advocate for Teva’s disclosure standards, policy, and public accessibility to data.

• PhD/PharmD with a minimum 6 years experience or a Master’s with a mnimum of 8 years experience
• Advanced degree in Life Sciences, Pharmacy, or Medicine.
• A minimum of 6 years of experience in Transparency and Disclosure

Experience Preferred:

• 6-8 years of experience in Transparency and Disclosure preferred.
• A broad understanding of the legal/regulatory requirements and guidelines with regard to clinical trial transparency and disclosure.
• Working knowledge of clinicaltrials.gov, clinicaltrialsregister.eu/CTIS databases, Policy 0070
• An understanding of the clinical drug development process, including clinical trial design, operations, and results analysis. Relevant experience in Regulatory Affairs.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Associate Director, Real-World Evidence (RWE) Statistics sits within Global Statistics & Data Science (GSD) and partners with cross-functional teams in Teva R&D to provide statistical strategy and technical leadership for analysis of Real-World Data (RWD) and other data sources to support lifecycle drug development. The key responsibilities include statistical input to the evidence generation planning, medical affairs and RWE research proposal reviews, study protocol and statistical analysis plan (SAP) development and execution, results interpretation, scientific presentations and publications, interactions with agencies, and RWE/statistical methodology research. In this role, your expertise will elevate data generation, inform decision-making, and ultimately improve patient outcomes.

• Lead RWE statistical input for evidence generation planning for assigned TAs/assets, collaborating closely with global and regional Medical Affairs, Health Economics, Value and Outcomes, and other R&D stakeholders.
• Actively engage in the development and review of study concepts and protocols, ensuring alignment with objectives, and appropriate sample size and statistical methods for scientific, regulatory, and market access needs.
• Lead or oversee SAP development and execution, including table, figure, and listing shells, and output review. Collaborate with programmers/analysts to ensure timely, high-quality statistical deliverables. Develop data review plans, interpret complex data, and ensure study results are scientifically robust and actionable.
• Provide in-depth statistical review for scientific publications and reports. Work closely with internal and external stakeholders to ensure appropriate statistical analysis and results are consistently applied in all scientific and regulatory documents, presentations, and publications.
• Contribute to external interactions with regulators, payers, and other agencies.
• Demonstrate excellent understanding of advanced statistical concepts. Take a leadership role in introducing innovative statistical methods (e.g., causal inference, bias and confounding control, AI/ML) into analysis plans to improve efficiency and validity of study results. Effectively explain statistical concepts to non-statisticians.

• PhD (with 4+ years of experience) or MS (with 6+ years of experience) in Biostatistics, Statistics, or a related quantitative field.
• Pharmaceutical or related industry experience required.
• Competence in RWE study design, statistical modeling, and AI/ML methods to observational data. Knowledge of methodologies for confounding control and bias minimization in observational studies highly desired.
• Expertise with multiple RWD sources (e.g., EHR, claims, registry data); familiarity with clinical trial design.
• Proficiency in programming skills in SAS, R, and/or Python; experience with cloud-based analytics platforms is a plus.
• Ability to build strong relationships with cross-functional partners to provide cutting-edge statistical solutions, drive data-driven innovation, and achieve high performance.
• Highly motivated to learn new methodologies and technologies, open-minded and adaptable, enthusiastic about innovation and making meaningful impact.
• Excellent writing and communication skills.
• Demonstrated leadership and project management abilities.
• Experience supporting HTA submissions, or regulatory interactions is preferred.
• Track record of publications or presentations in RWE methods is preferred.
• Familiarity with clinical trial data standards (ADaM/SDTM) and data privacy regulations is preferred.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.