Manager, Supplier Quality Management Program Management and Auditing
Manager Supplier Quality - Program Management & Auditing
Location: Bedford, MA
The Supplier Quality Management Manager is responsible for the Vendor Management program, that governs GxP services such as contract manufacturing, laboratory testing, research and material suppliers. This role will also serve as a lead auditor to ensure GxP vendors operate in accordance with US and EU regulatory requirements. We seek leaders with proven ability to work independently and collaboratively to achieve our goal of delivering products that transform the lives of our patients.
Essential Functions and Duties
- Quality Lead for the Vendor Management Program, which includes External Audits (i.e. on-site, remote and paper), Quality Agreements, Vendor Change Notification and Supplier Corrective Action Requests
- Serves as lead GxP auditor for external party audits that includes planning and conducting audits, issuing reports and evaluating audit responses
- Drafts, negotiates and maintains Quality Agreements between HMI and external parties
- Conducts routine evaluation and periodic reassessments of external parties
- Facilitates Vendor Change Notification process internally among HMI stakeholders
- Manages and monitors the Supplier Corrective Action Requests
- Maintains approved vendor list
- Issues and evaluates questionnaires for low risk suppliers
- Builds Supplier Monitoring process to establish risk-based approach for maintenance of external parties
Skills and Experience
· Bachelor’s degree in chemistry, biology, microbiology or equivalent
· Minimum 8 years of experience in the pharmaceutical/biotech industry with a minimum of 2 years’ experience in Supplier Quality or has been trained as a lead auditor.
· Comprehensive knowledge of quality principles and GMP, ICH and GLP regulations.
· Strong interpersonal skills; the ability to interact effectively with all levels within the organization, external third parties, and regulatory authorities
· Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
· Self-driven, independently motivated, detail-oriented, organized and excellent problem-solving ability.
- Effective decision maker that has demonstrated ability to assess and manage quality and compliance risks
- Previous leadership experience preferred.
Interested candidates should forward a cover letter and Resume / CV to firstname.lastname@example.org