Director of Quality Assurance
1 week ago
Head of Quality Assurance - Boston
Do you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below.
Responsibilities:
- Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements;
- Maintaining the high standards of quality at the site through managing and continuously improving the effectiveness of quality processes and systems;
- Developing productive and proactive relationships with regulatory bodies and customers;
- Identifying, developing, and retaining qualified people to lead the implementation of quality processes;
- Running an efficient and effective Quality system.
Requirements:
- Extensive relevant Quality experience, including quality assurance and regulatory;
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the EMA/EP and FDA/USP Guidance Documents for biologics;
- Good understanding of pharmaceutical biotech operations and/ or CDMO business;
- University degree in natural sciences or another field of science and having knowledge in biology (microbiology, molecular biology, immunology and biotechnology), chemistry (biochemistry and analytical chemistry);
- Work experience: preferably 5-7 years’ experience in management role (middle management) in biotechnology or pharmaceutical company;
- Proven direct supervisory experience. Demonstrated success in supervising a team
- Experienced in aligning individuals and teams to business objectives;
- Experience in managing by metrics.
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