Director, Development Quality Assurance
Job Title: Director, Development Quality Assurance
Company: Biopharma
Location: Remote; based in New Jersey, US
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
We work with a range of life sciences organizations across multiple industry disciplines, with one of our strongest portfolio’s in Clinical Operations. With US offices strategically located on the east coast (DC Metro) and west coast (San Diego) we connect rare life sciences talent with emerging companies nationwide.
Position Overview: Director, Development Quality Assurance
As a Director of Development QA, you will be reporting to the Executive Director of Development Quality Assurance. This role will serve as a strategic leader managing regulatory compliance and quality as it relates to GCPs.
Opportunity Highlights:
- Manage quality documentation (SOPs, CAPAs, Deviations)
- Oversee GCP activities to ensure data integrity and patient safety
- Mitigate GCP quality and compliance issues using strategic direction with cross functional working groups
- Provide knowledge and support to other staff members to develop additional auditing and quality sources
- Ensure the development and implementation of a strategic audit plan as according to SOPs and regulations
Position Requirements: Bachelor’s degree required
- BS Degree in Chemistry or related field; minimum 8-12 years of experience
- Experience supporting Phases I-IV, regulatory submissions, and/or approval
- Experience with effectively managing regulatory agency inspection and working with staff to help prepare for inspections
- Experience developing SOPs as well as reviewing internal regulatory, clinical, and medical processes to ensure they are accurate according to current SOPs
- Knowledge of risk-based quality systems approaches consistent with ICH E-6
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.
