Description
We are seeking a leader to manage a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organisation.
The successful candidate will provide guidance and coaching to colleagues, oversee department activities, ensure compliance with regulations, and communicate effectively with customers and partners.
Key Responsibilities:
- Provide leadership and guidance to a team of quality professionals
- Ensure site standards, policies, and procedures are aligned with global Pfizer Quality Standards and regulatory agency guidelines
- Oversee internal site systems audits, compliance performance indicator metrics, and gap assessments
- Manage and lead site’s QIP (Quality Improvement Plan) and IR (Inspection Readiness) Program
- Collaborate with cross-functional teams and regulatory agencies
Requirements:
- BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
- Experience in a cGMP environment, with a strong working knowledge of quality systems, aseptic manufacturing, and processes including Drug and Combination products
- Excellent written and verbal communication skills
- Strong people management experience
- Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent
Preferred Requirements:
- Understanding of device and combination product industry regulations
- Strong analytical and problem-solving skills
- Ability to work independently and make decisions
- Experience in interfacing with regulatory agencies during audits
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot