Senior Manager Quality Assurance

6 days ago

Jersey City, New Jersey, United States Clinical Dynamix Full time


Clinical Stage Pharmaceutical Company is looking for a Senior Manager, Quality AssuranceKey ResponsibilitiesProvide 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, investigations, etc.) Authorship/review/approval of additional SOPs/policies for GMP/GCP regulatory compliance, where there may be gaps identified.

Ensure compliance with the company's procedures and training requirements.
Facilitate GMP/GCP training of functional areas and develop appropriate training for personnel involved in the execution of related duties. 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 quality deliverables.

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 manufacturing facility.

Provide support in reviewing Clinical packaging records.

Develop and manage a risk-based Quality Management System for QA in compliance with applicable regulatory requirements (US) and company policies.

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.

Basic Qualifications:
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 Review5+ years of experience working directly within Quality Assurance/Quality Systems.
Thorough understanding of Regulatory compliance requirements for the US FDAFamiliar with Local, State, Federal, and international regulations Auditor training/experience or certificationStrong understanding of risk assessment and risk management fundamentals/toolsTeam and consensus builder, with definitive and authoritative decision-making ability

Preferred Qualifications:
B.S.

degree or an equivalent amount of relevant experience10-12 years of experience working within the Quality Assurance/Quality Systems, Clinical Operations, and/or Regulatory environment in the pharmaceutical or biotechnology industry.

Proficiency with software applications such as MS Office, Smartsheet, Veeva.
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 team.

Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment including leading/participating in projects.

Ability to independently analyze/resolve moderate to complex issues and to seek guidance as needed.
Effective written, verbal, and listening skills.

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