Senior Director of Quality Assurance
Location: Atlanta, GA
Work Schedule: Hybrid
Summary:
Our client is a leading biotechnology company based in the heart of Atlanta, Georgia. They are seeking an experienced and motivated individual to fill the role of Senior Director of Quality Assurance.
Responsibilities:
- Overseeing GxP/FDA 21 CFR Part 210 compliant operations
- Developing and implementing auditing programs
- Ensuring adherence to regulations within various departments such as manufacturing and clinical development teams
- Implementing procedures necessary for successful FDA inspections
- Managing relationships with external partners
Qualifications:
The ideal candidate for Senior Director of Quality Assurance should possess relevant qualifications including:
- Bachelor's degree in related field
- At least ten years' experience working in a similar leadership position managing QA/RA functions at pharmaceutical/biotech companies;
- Experience developing policies/procedures/systems (EPM/QMS);
- Proven track record successfully guiding audits by Regulatory bodies like USFDA/EU etc.,
Skills Required for Senior Director of Quality Assurance:
- Strong knowledge on cGXP's requirements,
- In-depth understanding/experience interpreting current Good Manufacturing Practices (cGMP), Food & Drug Administration(FDA)/International Conference on Harmonization(ICH),
- Excellent communication skills both written/oral
- Leadership Skills - Ability to manage change through influence without authority
If you believe that this opportunity aligns with your values and goals, then we encourage applying today!
