Associate Director-Quality Assurance (QA-CMC)

Associate Director-Quality Assurance (QA-CMC) Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support drug development from Phase 1 to late-stage development. This position will provide CMC quality leadership within the organization and across our Contract Manufacturing Organizations (CMOs) and Contract research labs (CROs). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical and commercial products follow cGMP framework and guidelines. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate). At Company, we are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.

Key Responsibilities

• Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors. Participate and provide guidance on any site and vendor-related quality issues identified.
• Provide Quality oversight of protocols, starting material, finished product specifications, API and drug product manufacturing, analytical and stability reports.
• Ensure that CMC quality systems, validation, product specifications, product release, reference standard and stability programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities.
• Ensure CDMO manufactured products meet Health Agencies regulations and company standards. Perform quality review of analytical documentations for CMC programs, including method transfer, qualification, validation protocol, in-process controls, data packets, CoA, and stability protocols/reports.
• Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA.
• Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.)
• Facilitate GMP/GCP training of functional areas and develop appropriate training for employees and contractors involved in the execution of related duties.
• Performs assessments and QA review of source documents, change controls, deviations, quality events, CAPA, root cause analysis, product impact assessment, investigations, including OOS investigations and other reports for accuracy. Develop and manage a risk-based Quality Management System for QA in compliance with applicable regulatory requirements (US) and company policies.
• Participate in the supplier qualification program and provide oversight of contractors and consultants to ensure timely and quality deliverables. Assist in the development, approval, maintenance, review, management of agreements (such as QAA, MSD, consulting agreements etc.,).
• Work with CMOs to create, and keep current with Quality Agreements, Quality issues to ensure quality standards are met, and resolve issues promptly and effectively.
• Support the coordination and management of regulatory agency inspections, and inspection readiness efforts which may include mock internal inspections and vendor audits.
• Manage inspection commitments, post-inspection activities, and corrective/preventative actions in a timely manner.

Basic Qualifications:

• B.S. Biological Sciences, Chemistry or relevant discipline and a minimum of 10 or more years' related experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience or an equivalent combination of education. Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles.
• 5+ years of hands on experience with Quality Management System including Electronic Document Management System (Veeva preferred), managing documents lifecycles-Draft to Effective/approved, Initial to Final and Periodic Review
• Thorough understanding of Regulatory compliance requirements for the US FDA
• Auditor training/experience or certification
• Strong understanding of risk assessment and risk management fundamentals/tools
• Knowledge of FDA, EU, ICH requirement for GMP and related areas, e.g., 21 CFR 210 & 211, Part 11 / Annex, ICH Q7 etc.
• Experience in reviewing specifications, MBRs, EBRs, stability protocols, method validation protocols, and reports etc. for early and late-stage drug substance and drug products.
• Knowledge and understanding of quality management systems is required, with a focus on batch release requirements for clinical trials and commercial product monitoring is required.
• Proficiency in creating QMS SOPs, work instructions, good documentation practices.
• Experience in auditing/vetting of CDMOs.
• Small or mid-size company experience preferred with experience leading project(s) with minimal supervision.
• Proven interpersonal and relationship building skills with the ability to work collaboratively as a member of a cross-functional team.
• Excellent organizational skills, attention to details and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment including leading/participating in projects.
• Ability to react to situations with a "sense of urgency" and responsibility.
• Employment is contingent upon satisfactory results of a pre-employment background check, drug screen, proof of full COVID-19 vaccination and proof of COVID-19 booster vaccination.

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