Senior Manager in Regulatory Submission Compliance overseeing CMC documentation and submissions. Ensuring high - quality regulatory compliance for clinical and commercial activities in Biotech.
About the role
- Operations Compliance Lead at Pfizer responsible for driving compliance and performance excellence across teams. Conducting data analytics, leading initiatives, and ensuring GMP inspection readiness.
Responsibilities
- Conduct data analytics/review to enable proactive detection of quality and compliance signals and trends.
- Drive remediation plans based on the signals and trends.
- Lead successful and timely execution of quality and compliance improvement initiatives.
- Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness.
- Provide technical SME support and BOH response writing/review.
- Work in coordination with the QO Leads and QPL to drive the site regulatory strategy for key products, site digital strategy and continuous improvement initiatives.
- Provide technical inputs to evaluate investigations, product and process issues, including the ability to identify root cause and corrective and preventative actions, and accountable to provide leadership to drive issues to timely resolution.
- Provide rapid and effective cross-site coordination of significant investigation activities associated with low bioburden/sterile products.
- Prepare and facilitate Quality/OpU Quality Review meetings.
Requirements
- BA/BS with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience.
- Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.
- Proven leadership skills and ability to work across functions with all levels of the organization.
- Demonstrated skills in analyzing, organizing, and project management with a high sense of urgency.
- Must be fluent in English.
Benefits
- Health benefits to include medical, prescription drug, dental and vision coverage.
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
- Paid vacation, holiday and personal days.
- Paid caregiver/parental and medical leave.
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