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Director of Quality Assurance
3 months 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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