Associate Director Quality Assurance Pharmaceuticals
Company: Affinity Executive Search
Location: Jersey City
Posted on: September 17, 2023
Associate Director Quality Assurance GCP and GMP and must have
strong Document Control experience
- Provide leadership, strategy, and compliance oversight in
accordance with Good Manufacturing Practices (GMPs) for internal
processes, GMP Service Providers, including but not limited to
CMOs, Third Party Vendors, etc.
- Responsible for Management and maintenance of the Veeva Quality
Docs System, including document drafting/Authoring, reviewing,
approving, and finalizing internal quality documents (SOPs,
- Authorship/review/approval of additional SOPs/policies for
GMP/GCP regulatory compliance, where there may be gaps
- Ensure compliance with the company's procedures and training
- Facilitate GMP/GCP training of functional areas and develop
appropriate training for personnel involved in the execution of
- Support the administration of the company's training program in
Learning Management system.
- Participate in the supplier qualification program and provide
oversight of contractors and consultants to ensure timely and
- 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.
- Reviewing and approving documentation such as Manufacturing
Batch Records (MBRs), product specifications, change controls,
deviations and CAPAs associated with the operations at the
- Provide support in reviewing Clinical packaging
- Develop and manage a risk-based Quality Management System for
QA in compliance with applicable regulatory requirements (US) and
- Participate and provide guidance on any site and vendor-related
quality issues identified.
- 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.
- Willing to assist with other duties as assigned.
- B.S. Biological Sciences, Chemistry or relevant discipline and
a minimum of 8-10 years' related experience in the
pharmaceutical/biotechnology industry with increasing
responsibility and relevant QA experience or an equivalent
combination of education.
- Hands on experience with Electronic Document Management System
(Veeva preferred), managing documents lifecycles-Draft to
Effective/approved, Initial to Final and Periodic Review
- 5+ years of experience working directly within Quality
- Thorough understanding of Regulatory compliance requirements
for the US FDA
- Familiar with Local, State, Federal, and international
- Auditor training/experience or certification
- Strong understanding of risk assessment and risk management
- Team and consensus builder, with definitive and authoritative
- B.S. degree or an equivalent amount of relevant
- 10-12 years of experience working within the Quality
Assurance/Quality Systems, Clinical Operations, and/or Regulatory
environment in the pharmaceutical or biotechnology
- Proficiency with software applications such as MS Office,
- Proficiency in creating QMS SOPs, Good Documentation Practices,
and quality review methods.
- Small or mid-size company experience and ready to lead
project(s) with minimal supervision.
- Proven interpersonal and relationship building skills with the
ability to work collaboratively as a member of a cross-functional
- Excellent organizational skills and the ability to manage
concurrent deliverables and work effectively in a challenging,
milestone-driven environment including leading/participating in
- Ability to independently analyze/resolve moderate to complex
issues and to seek guidance as needed.
- Effective written, verbal, and listening skills.
Keywords: Affinity Executive Search, Jersey City , Associate Director Quality Assurance Pharmaceuticals, Executive , Jersey City, New Jersey
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