Project Specialist jobs

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.

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
• Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Provide leadership to cross functional teams for regulatory issues and questions.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required

• Bachelor’s degree or equivalent experience is required
• Master’s degree or PhD in science, math, engineering, or related discipline preferred

• Minimum 5 years of relevant experience
• 2+ years of medical device regulatory experience preferred
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
• Advanced knowledge of ISO 13485
• Advanced knowledge of product life cycle, product development process, design control and change control
• Experience interacting with government agencies
• Excellent oral communication, technical writing, and decision-making skills

• Attention to detail with planning, time management and organizational skills
• Regulatory compliance competency including Quality Systems
• Experience with administration and safety systems preferred
• Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.

• 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).

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred