Senior Manager, Pharmacogivilance Quality Assurance - United Kingdom
- The Senior Manager/ Manager of Research and Development Quality Assurance (RDQA) for Pharmacovigilance (PV) is an independent contributor who is responsible for performing quality assurance activities to ensure that the company Global PQS team is adhering to applicable regulations, industry standards, company policies, procedures, and quality standards in support of the Quality Management System.
- In addition, the Senior Manager/ Manager will support RDQA/ PV leaders in providing strategic input and tactical implementation for pharmacovigilance activities and projects, identify and communicate compliance risks, oversee action plans to mitigate risks (if applicable), and be actively involved in inspections and inspection-readiness activities.
- This person will participate in interdepartmental teams representing RDQA PV and at times may be asked to perform RDQA activities to support other GxP areas, quality operations, and global quality systems.
- Maintain professional expertise and knowledge of local and international regulations relative to pharmacovigilance and quality
- Support RDQA PV Directors in developing and executing global RDQA PV strategy and implementing associated Quality Management System
- Review internal and external SOPs; and participate in the development of SOPs
- Support update of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documents
- Contribute to the development and implementation of strategic audit plans for pharmacovigilance activities that include service providers, vendors, business partner, and internal audits.
- Participate in writing Requests for Proposals (RFPs) or Work Orders when engaging with vendors that will be conducting audits on behalf of the company and/or pharmacovigilance agreements (in collaboration with relevant stake holders) when engaging with vendors to perform activities on behalf of the company.
- For pharmacovigilance audits conducted directly by company personnel, or conducted by a vendor on behalf of the company (external audits) participate as lead and/or co-auditor and/or oversee and engage with the vendor.
- Present QA findings/observations to in-house staff and, if appropriate, to the responsible service provider, vendor, or partner company.
- Contribute to evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
- Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g. runner, scribe, backroom lead, SME preparation, etc.)
- Identify and escalate critical quality issues to senior RDQA management
- Contribute to the development of continuous quality process improvements and the identification of identifying root causes for investigations
- Represent RDQA within interdepartmental teams / project groups
- Maintain current training in accordance with the company RDQA PV training curriculum
- This position may require up to 20% travel
- Required Knowledge, Skills, and Abilities
- Established Pharmacovigilance or Quality professional with proven leadership experience in pharmaceutical, or biotechnology industry
- Strong GVP/GCP knowledge & expertise;
- Auditing experience preferred
- Required/Preferred Education and Licenses
- Bachelor’s degree in business or life sciences required
- Lean Sigma certification preferredRequired Competencies
- Excellent written and verbal communications skills
- Ability to work in an entrepreneurial and fast-paced culture
- Knowledge of Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP) preferred
- Self-directed and ability to take action as needed with limited oversight
- Ability to collaborate and partner with various internal and external business partners
- Ability to work in a team environment
- Disciplined, detail orientated, and strong time management skills