Key skills
AgileLeadershipRisk ManagementCommunicationCritical Thinking
About this role
Role Overview
- Approve and deliver regulatory stability reports and protocols.
- Ensure that all required external testing at CTOs are completed following all cGMP and internal requirements for quality and timeliness.
- Ensure stability studies at CMO/CTO sites are conducted according to approved protocols and ICH guidance.
- Serve as stability SME for investigations and stability administration document approvals.
- Manage all required activities to support external testing of stability studies.
- Trend stability results to support product expiry and expiry extensions.
- Author stability related sections in regulatory submission, including responses to questions and post-marketing commitment support.
- Utilize risk management tools to identify and migrate CMO/CTO quality and compliance risks, ensuring CMO/CTO sites are in a state of continuous inspection readiness.
- Provide as needed support during regulatory inspections and compliance audits for stability management activities.
- Focus on Safety and GMP compliance as operational priorities and as performance measures that should be included in metrics.
- Know the processes and global stability procedures and being accountable for the principles and practices of good documentation and data management/data integrity (ALCOA).
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 in Chemistry or Pharmacy.
- Demonstrates strong technical/functional knowledge needed to coach direct reports on day-to-day activities.
- Strong communication (oral and written) and teamwork skills.
- Demonstrated critical thinking skills; close attention to detail and accuracy and ability to work both independently and in a team environment.
- Self-motivated and willing to learn new and changing responsibilities; agile response to constantly changing conditions and priorities.
- Demonstrated commitment to values-based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies.
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Paid holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage