Associate Director-Quality Assurance
4 weeks ago
Clinical Dynamix is seeking a highly experienced and innovative quality leader to join our Quality team as Associate Director, Quality Assurance. This role will provide CMC quality leadership within the organization and across our Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).
The ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles. They will be responsible for providing quality leadership, strategy, and compliance oversight to CDMOs, CMOs, CROs, CPOs, Third Party Vendors, and participating in the supplier qualification program.
Key Responsibilities:
- Provide quality leadership, strategy, and compliance oversight to CDMOs, CMOs, CROs, CPOs, Third Party Vendors.
- Participate and provide guidance on any site and vendor-related quality issues identified.
- 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.
Requirements:
- B.S. in 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.
- 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.
Preferred Qualifications:
- Knowledge of FDA, EU, ICH requirements 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.
What We Offer:
- 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.
Equal Opportunity Employer:
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