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VP of External QA
(All applicants please send resume in Word format to email address shown at the bottom of description)
Provide leadership for the company’s long term outsourcing strategies for bulk manufacturing, filling, packaging and logistics, and management of strategic quality relationships with our domestic and international commercial partners. They will be responsible for effectively managing a growing group of staff (currently 27 employees). This person is accountable for three key areas:
External Collaborations:
-Work with collaborators and partners to ensure that expectations for quality and compliance are documented and met at our partner locations
- Work with Manufacturing Collaborations to identify and evaluate new business opportunities and assist in the development of new business partners (e.g. due diligence, Quality agreements, supply contract negotiation, etc...)
- Establish & develop cooperative relationships with new and existing partners. Identify partner issues & recommend appropriate solutions
- Actively manage partner relationships, including quality agreements, planning & project management
Contract Manufacturing:
-Develop and ensure robust processes for the on-going management of contract manufacturing to ensure expectations for quality and compliance are documented and met at our contractor locations
- Work with the Manufacturing Collaborations & Supply Chain Strategic Planning function to develop a robust long term outsourcing strategy for bulk manufacturing, filling, packaging, warehouse and distribution
- Conduct a review of all existing contracts and develop a plan for renegotiating where necessary
- Work with the legal group to develop robust templates for quality agreements to expedite and improve the quality of the contracting process
- Negotiate new quality agreements with contract manufacturers and collaborators
- Direct the planning & coordination of quality tech transfers to contractors
-Ensure all contract manufacturing have “qualified “status
-Collaborate with Corporate Compliance to ensure all CMO’s maintain an “inspection readiness” state
Supplier Quality
- Work with Suppliers to ensure the correct level of material & resources are in place to support manufacturing operations
- Ensure expectations for quality and compliance are documented and met at our supplier locations
- Ensure corrective actions identified through audits and promptly implemented
-Ensure all suppliers have qualified certification status
Job Qualifications:
- Candidate must have ability to influence the development of the pharma/biotech contract manufacturing industry in a way that will support strategic goals
- Ability to travel domestically and internationally (50-75%) to confer with partners and/or contract manufacturing
Previous Experience:
- 15 years quality experience in biotech or pharma industry
- In-depth knowledge of the pharma/biotech contract manufacturing/collaborations industry
International business experience required
- Licensing experience
- New product launch experience
- New plant start up experience
- Knowledge of wide range of technologies
- Experienced in negotiating Quality Contracts
Technical Experience:
- Quality and/or Sterile Processing experience
- Design and production of biotechnology dosage forms
- Design and production of medical devices
- Pharmaceutical Packaging experience
- Negotiation & contract development experience
Education Background:
B.S. in Life Sciences, Business or Engineering
MBA or Finance qualification preferred
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Position Type:
Employee
Ref Code: 005 |
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