IDRx · 16 hours ago

Associate Director/Director, GMP Quality Assurance

Cambridge, MA

Full-time

Remote

Director/Executive

10+ years exp

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BiotechnologyLife Science

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Responsibilities

Develops and implements the Company’s GMP quality strategy and objectives in alignment with its mission and regulatory requirements

Ensures all clinical and commercial products comply with relevant regulatory standards. Stays abreast of changes in regulations and guidance, adjusting quality systems, as necessary

Oversees the development, implementation, and maintenance of GMP quality systems, including document control, change control, CAPA, risk management, and audit programs

Oversees GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; provides oversight of appropriate CAPAs associated with deviations and investigations

Leads complex GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; provides oversight of appropriate CAPAs associated with deviations and investigations

Develops a risk-based GMP audit program; oversees and conducts (where applicable) GMP audits

Ensures the timely release of clinical and commercial batches, oversees the review and approval of all GMP related documentation, and ensuring compliance with specifications and regulatory requirements

Acts as the primary GMP quality contact for regulatory agencies, and oversees the preparation and submission of required documents

Oversees the quality aspects of supplier and contract manufacturing organization (CMO) qualification and ongoing performance evaluation

Implements process improvements and quality best practices

Works closely with Clinical and Commercial Operations, Regulatory Affairs, and other departments to integrate quality into all aspects of product development and supply chain

Advise Company's the Head of Quality on the implications and risks related to key GMP Quality issues and important strategic decisions, on a timely basis

Qualification

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GMP Quality AssuranceFDA regulationsEMA regulationsLeadership experienceQuality ControlQuality strategiesSmall molecule pharmaceuticalsGMP auditsMentoring skills

Required

Bachelors or Masters in a scientific/technical discipline and 10+ years of experience in the pharmaceutical/biotechnology industry, with at least 5 years in leadership roles within Quality Assurance / Quality Control.

Experience in managing quality at GMP contracting companies.

In-depth knowledge of FDA, EMA, and other regulatory standards.

Strong leadership, communication, and interpersonal skills.

Demonstrated ability in setting successful quality strategies, building and leading the function within the company.

Demonstrated ability to think strategically and execute tactically.

Ability to thrive within a small organization where both leading and conducting work is required.

Effective leader of others and ability to mentor and develop team members.

Proven experience in leading successful regulatory inspections and GMP audits.

Strong analytical and problem-solving skills.

Effective written and verbal communication skills.

Ability to travel when required (including international).