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About the role
Key responsibilities & impact- Develop and lead complex projects, while ensuring quality and inspection readiness.
- Provide leadership and mentoring of vendor operations colleagues.
- Responsible for Qualification and Oversight activities for a variety of vendors.
- Approve external investigations, CAPAs, change controls, Quality Agreements, to maintain compliance with vendor operations.
- Collaborate with PharmSci colleagues and business lines to develop procedures that increase efficiency and maintain high-quality standards.
- Represent Vendor Operations Quality as a subject matter expert at cross-functional forums and projects, supporting global manufacturing sites and regulatory operations.
- Provide clear, direct, and timely communication to stakeholders, driving customer relationships, delivering quality improvement recommendations, and implementing continuous improvement initiatives.
Requirements
What you’ll need- Must-Have BA/BS with 6+ years of experience; OR MBA/MS with 5+ years of experience; OR PhD/JD with 1+ year of experience; OR MD/DVM with any years of relevant experience.
- Experience supporting or leading Quality audits and developing/managing remediation plans.
- Relevant pharmaceutical experience including previous Quality Assurance experience conducting a broad range of audits and vendor management activities.
- Extensive experience with Quality Agreements.
- Broad knowledge of relevant regulatory current Good Manufacturing Practices (part of GxP) audit frameworks that apply to pharmaceutical operations, its trends and expectations, and familiarity with other Good Practice concepts and global regulations.
- Strong verbal and written communication, including presentation skills.
- Strong project management skills.
- Ability to influence and lead cross-functional teams.
Benefits
Comp & perks- Eligible for Relocation Package – NO
- Secondment 12-18 months
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality AssuranceQuality auditsremediation plansQuality AgreementsGood Manufacturing PracticesGxPvendor managementproject management
Soft Skills
leadershipmentoringcommunicationpresentation skillsinfluencecross-functional team leadership
Certifications
BABSMBAMSPhDJDMDDVM