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Director of Quality Assurance

Boston, MA, United States

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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