Principal Consultant jobs in United States, Pennsylvania, Newtown Township

• Drive program delivery for programmatic aspects of due diligence through post-integration
• Build and communicate a common methodology for delivery/reporting across all workstreams
• Manage workstream accountability across the organization, including into the C-suite
• Maintain focus of workstream leads on key value-drivers aligned to the core deal thesis
• Lead the program execution of transaction integrations across all functions to ensure delivery in partnership with Corporate Development and other key stakeholders
• Participate in pipeline review to provide insight into future M&A integration delivery needs, budgeting, strategy, and resource planning to achieve successful outcomes
• Provide and maintain recurring reporting and score-carding of functional and business unit performance against plans of record and IMO Project Plans
• Applies lessons learned from prior deals to continuously improve due diligence and integration planning practices
• Work within Corporate Development to build due diligence services to provide targeted insights, experience-based observations, and EBITDA and cash improvement opportunities to guide investment determinations
• Provide proactive decision support to executives and team members
• Present data to senior stakeholders and serve as point-of-contact for integration leaders at entities being evaluated / acquired
• Mobilize the internal resources and external partners to ensure effective and timely delivery
• Other duties as assigned

• Bachelor's Degree in Finance or Business Administration or equivalent experience required
• Master's Degree preferred

• Minimum 8 years of relevant experience required
• 4-6+ years of consulting or project management experience, ideally with direct exposure to M&A and integration planning / management required

• Experience collaborating with cross-functional project teams.
• Exceptional interpersonal skills, communication capabilities and the ability to influence multiple stakeholders with competing / conflicting interests.
• Capable of organizing information succinctly and communicating to all levels of an organization.
• Experience multi-tasking to lead and execute multiple projects in parallel.
• Strong presentation skills and ability to present material and complex matters in a succinct and organized manner
• Ability to think critically in tactical and strategic dimensions simultaneously.
• Demonstrated ability to effectively work across various functions in order to ensure deliverables are met against required timelines.
• Ability to prioritize tasks in real time and exercise judgment in high-stakes environment.
• Ability to quickly establish credibility, trust and support with both internal and external constituents.
• Strong ability to communicate effectively with leaders at the most senior levels within the corporation.
• Ability to interface effectively with all levels and functions both inside and outside of the organization.
• Able to comply with the company’s safety and quality policies at all times.

• Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, tight deadlines, problem solve, and prioritize
• Ability to make work independently and sound decision making
• Observe and interpret situations, analyze and solve problems

• Lead and direct E2E design and architecture for SAP implementations as well as leading/managing global SAP production support.
• Possesses solid understanding of overall vision and business needs and utilize specialized expertise in SAP Production Planning to collaborate with Quality and Operations to define detailed User Stories for Digital and Transformation (D&T) enablement of business needs. This includes interpreting any issues and recommending solutions or best practices.
• Utilizes knowledge of best practices to help define strategic direction, help determine business needs and design and deliver technical solutions to key stakeholders and in partner with Application and Infrastructure.
• Essential core member of agile sprint team(s) to configure and develop optimal technical solutions / features.
• Provide technical delivery of functionality to meet defined business requirements as described in User Stories.
• Provide system support and maintenance in alignment with standards and process set within the ERP Services Delivery model, West policies, and procedures as well as regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP.
• Create and maintain system lifecycle documents in accordance with West policies and procedures, including creation and maintenance of SOPs, SOIs and Job Aids.
• Work within and participate in the Change Control process.
• Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual, and predictable attendance.
• Other duties as assigned

• Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Spearhead the mapping of map business requirements to optimal technical solutions.
• People Management, Work distribution, Performance evaluation, Cross functional team coordination.
• Ability to drive and create outcomes that are tangible.
• Mentor and coach the team to perform their task successfully. Focus on team building and development.
• Create and maintain project charters and plans, capital requests, budgeting and project management in accordance with the Project and Portfolio Management process and West policies and procedures.
• Uses breadth of expertise to solve complex problems.
• Provide system support and maintenance in alignment with standards and process set within the ERP-SAP S4 Hana Services Delivery model, West policies and procedures as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP.

• Deep expertise, understanding and knowledge of SAP – system functionality and technical understanding of SAP S4HANA Production planning, Manufacturing, Quality and related areas ( PP, QM, EWM)
• Should have experience in integrating SAP S4HANA
• SAP S4 HANA knowledge required, ideally actively involved in implementation of production and Quality
• Ability to work autonomously in a fast-paced & complex environment with a self-motivated work ethic; utilize sound judgment with an ability to manage multiple priorities with a sense of urgency.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• People management experience

• Bachelor's Degree or equivalent experience in Computer Science or Information Systems required

• 8-10 years of related work experience Bachelor’s degree Computer Science, Information Systems, or other related field or equivalent experience.
• Preferred but not required: Agile & Scrum Certification, ITIL

The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures all improvements align with global quality and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system validation, audit trails, electronic signatures, and data storage and retention.

• Responsible to identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories.
• Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements.
• Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention.
• Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation.
• Identify and implement meaningful metrics and KPI’s to measure and improve WSS laboratory compliance.
• Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV).
• Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication.
• Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.

• Bachelor’s Degree and/or Masters in Science Technology or Engineering.
• Master's Degree preferred

• 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry
• Expertise of cGMP requirements, ISO standards and FDA regulations

• Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies.
• Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group.
• Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, 21 CFR 11, ISO 14971
• Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired.
• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Thorough understanding of validation activities and risk management principles and techniques
• Fluent in English
• Excellent written and verbal communication skills
• Strong problem-solving and critical thinking skills
• 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.

• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with clients.

· Develop, optimize, and execute biomarker assays (e.g., ELISA, multiplex immunoassays)

· Perform RT-PCR and qPCR analyses for gene expression studies

· Maintain accurate and organized laboratory records and documentation.

· Analyze experimental data and contribute to technical reports and presentations.

· Demonstrates knowledge of state-of-the-art principles and techniques

· Ensure compliance with laboratory safety and quality standards

Minimum Qualifications

· B.S. degree in Biology, Biochemistry, Molecular Biology, or related science with a minimum of 5 years of experience, or M.S. degree with a minimum of 3 years of experience in the biotech/biopharma or CRO industry.

· Experience in biomarker assay method development, qualification/validation and sample analysis in support of preclinical or clinical studies

· Strong attention to detail, organizational skills, and ability to work independently

· Solid understanding of regulatory bioanalysis guidelines and relevant clinical practices

· Effective communication and teamwork skills

Preferred Qualifications

· At least 5 years of experience in biotech/biopharma or CRO

· In-depth knowledge of ligand binding assays and other bioanalytical methodologies

· Experience with NanoString Technology is a plus

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
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment

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