Senior Manager – PV Quality Compliance
Bristol Myers Squibb
full-time
Posted on:
Location: 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
Tech Stack
TableauTypeScript
About the role
- Collaborate with Patient Safety (PS) Global Process Leads (GPL) and Global Process Owners (GPO) to develop a quality/compliance framework to assess health of the processes
- Ensure quality oversight of PS processes through continuous monitoring of regulatory compliance and risk mitigation, adhering to all applicable GVP guidelines, regulations, and inspectorate expectations
- Develop and execute quality and compliance monitoring activities for PS processes
- Collate data from PS GPL and GPO, PV Compliance and QRM Team and analyze datasets to identify trends, patterns, and insights
- Create and present reports and visualizations to stakeholders
- Collaborate between subject matter experts and the Head of PV Process Excellence to drive continuous quality improvement
- Evaluate effectiveness of QM programs and recommend revisions to strategy
- Ensure effective communication with key PS stakeholders and escalate suspected compliance or quality concerns
- Plan remediation actions when vendor performance or compliance expectations fall short
- Partner with Global Process Owners/Leads and Director PV Process Excellence to identify opportunities for process improvement
- Participate and provide information in support of PS inspections and audits and collaborate with SMEs and PV Quality Assurance
- Define quality and compliance business requirements and collaborate with IT for timely delivery of enhancements and new functionalities
Requirements
- B.S.N./RN, B.A./B.S./M.S. (Life Sciences); B.S. Pharm./R.Ph./Pharm.D. or equivalent
- 8 plus years pharmaceutical industry experience, including significant pharmacovigilance, drug development, clinical development or regulatory affairs experience
- Extensive knowledge of worldwide regulations pertaining to pharmacovigilance
- Proven experience with analyzing data from multiple sources, with a focus on pharmacovigilance or drug safety
- Proficiency in data visualization tools such as Tableau, Power BI, or AI and machine learning similar strongly preferred
- Excellent analytical and problem-solving skills with keen attention to detail
- Prior quality and compliance related experience in pharmacovigilance preferred
- Prior experience with providing guidance to senior management on regulatory and compliance issues germane to pharmacovigilance
- Successful and creative negotiation of difficult compliance issues
- Demonstrated ability to work in a complex, changing environment and be accountable for actions and results