Job details

Director, GMP Quality Assurance

Gossamer Bio is seeking a Director of GMP Quality Assurance to oversee compliance and quality functions for drug manufacturing. The ideal candidate will have extensive experience in QA within a biopharmaceutical context.

Skills

GMP compliance knowledge
Leadership skills
Regulatory documentation
Interpersonal communication

Responsibilities

Oversee batch record review and disposition for drug substances and products.
Conduct and support audits of Contract Manufacturing Organizations.
Establish metrics to evaluate the effectiveness of Quality Systems.
Develop and maintain Quality Agreements with CROs.
Provide oversight for Gossamer’s document control program.

Education

Bachelor's degree in scientific discipline
Advanced degree preferred

Benefits

Medical, dental, and vision insurance
401(k) with matching
Long-term incentive plan
Vacation and sick leave
Work, personal, and family time off

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By Gossamer Bio

Gossamer Bio is a clinical-stage pharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. The headquarters is located in San Diego, Califo...

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FUNDING

Private

DEPARTMENTS

Quality Assurance

SENIORITY LEVEL REQUIREMENT

Senior

INDUSTRY

Health Care

TEAM SIZE