Associate Director Quality Assurance

Confidential; Cranbury Township (NJ); On-site; USD 100,000 - 180,000; Full time

Job summary

A leading global biologics technology platform is seeking an Associate Director for Quality Assurance in Cranbury, NJ. This role focuses on establishing and improving Quality Management Systems supporting GMP clinical manufacturing. Successful candidates will have extensive experience in the pharmaceutical industry, strong problem-solving skills, and the ability to lead quality initiatives. The position offers a competitive salary range of $100,000 to $180,000 annually.

Qualifications

• Minimum 14 years of experience in pharmaceutical/biotechnology industry.
• In-depth knowledge of cGMP and guidelines.
• Hands-on experience with pharmaceutical system validation.
• Experience with Quality Management Computer Systems.

Responsibilities

• Establish and continuously improve Quality Management Systems.
• Review clinical batch records and associated deviations.
• Lead the implementation of key performance indicators for QMS.
• Manage internal audit programs and process improvements.
• Recruit, train, and manage staff.

Skills

Critical thinking

Problem-solving

Technical writing

Communication

Team collaboration

Adaptability

Tools

Master Control

SAP

Job description

This range is provided by Confidential. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Compensation

Base pay range: $100,000.00/yr - $180,000.00/yr

Job Title: Associate Director, Cranbury Quality Assurance

Work Location: Cranbury, NJ

Overview

This Company is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing with locations in U.S., China and Europe.

The Associate Director, Quality Assurance will be responsible for the establishment, implementation and continuous improvement of Quality Management Systems in support of Contract Development Manufacturing operations at the Cranbury Site, with initial focus on the GMP quality elements for the Cranbury site release for cGMP clinical manufacturing.

Responsibilities

• Leverage global quality systems, collaborate with cross-functional teams to implement and maintain Quality Management Systems including but not limited to SOPs, CAPA and internal audit programs.
• Own clinical batch disposition: thorough review of executed batch records, associated deviations and impact assessments, change controls and other quality systems to determine acceptability of final batch product quality and disposition.
• Lead the development, implementation and continuous monitoring of key performance indicators and quality indicators, metrics/dashboards to assess QMS effectiveness periodically.
• Identify gaps/deficiencies in site QMS, lead/track remediation efforts and progress.
• Lead the effort to foster a quality mindset across functional departments to ensure consistent, science and technology-based, risk-averse decision making process.
• Support client audit/regulatory inspection processes.
• Manage/support internal audit programs and process improvements for quality systems.
• Ensure timely and effective quality support of commitments to clients/corporate.
• Represent quality organization for client business visits.
• Act as the QA lead/point of contact for clients, provide QA input/strategy/support for client’s Quality Management requirements.
• Review and approve quality documents including SOPs, OJTs, and batch records.
• Review and approve validation documentation and lifecycle documentation, including User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, traceability matrix, system validation plans/reports, SOPs, Change Control Documentation, and Risk assessment reports, etc.
• Manage event and deviation investigations, change control and CAPA.
• Follow SOPs to perform routine activities such as periodic review, account audit, Data Integrity audits.
• Recruit, train and manage staff.

Qualifications

• Minimum 14 years of experience in the pharmaceutical/biotechnological industry; experience in pharmaceutical/biotechnological GMP batch disposition strongly preferred.
• In-depth knowledge of cGMP and guidelines/requirements.
• In-depth knowledge and hands-on experience with pharmaceutical system validation.
• Experience with Quality Management Computer Systems, Master Control, SAP.
• Experience in managing and developing staff.
• Critical thinking and solid problem-solving skills with demonstrated ability to exercise sound QA judgment based on science and technology.
• Excellent technical writing and communication skills.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.
• Ability to adapt to fast-paced and changing conditions; strong sense of urgency to maintain project deadlines.

EEO Statement

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.