Director, Quality Assurance (Baltimore, MD)
Hiring Company Industry: Biotech/Pharma Number of Employees: 1 – 100 Employees
Total Compensation: $130K – $150K Location: Baltimore, MD
My client is an expanding drug development company focused on the oncology therapeutic area.
Job Summary:
The position involves direct oversight of quality assurance activities for drug product in clinical trials and then commercialization. Responsible for development and implementation of sound quality strategies for the company’s oncology products. Serve as liaison to the FDA and appropriate Regulatory branches. Oversight responsibilities include all GCP, GLP, GMP and quality assurance/control activities.
Major Job Duties Include:
• Direct Quality Assurance activities for sourcing of raw materials, product development, clinical supply manufacturing & characterization
• Maintain and improve Quality System including preparing and modifying SOP’s
• Provide leadership toward the development of in-house GLP and GMP activities
• Ensure corporate compliance with SOP’s
• Contribute to the preparation of CMC sections for IND and NDA submissions.
• Contribute to the development of new analytical methods for the testing of products
• Interface with US and International Regulatory authorities as necessary.
• Work in a cross-functional team and represent Quality at team meetings.
• Provide strong leadership and management skills in an entrepreneurial environment
• Contribute to the development and approval of process/method validation protocols and reports.
• Audit and oversee activities of outside contract manufacturers, suppliers and consultants
Background Required:
A minimum of 10 years of Quality Assurance experience in biotech or pharmaceutical industries.
Advanced technical degree with a B.S Degree in Chemistry and a PhD preferred.
Specific Experience/Skills Required
• Knowledge of parenteral drug development processes and international quality and regulatory requirements.
• Hands-on manufacturing experience of a pharmaceutical or biotech product required
• Experience in developing, implementing and maintaining quality systems and processes.
• Experience with the development of analytical methods development for new products
• Experience in drafting CMC documents for regulatory submissions.
• Experience with regulatory requirements for scientific protocols
• Experience in validation of manufacturing processes.
• Strong analytical skills combined with sound business and scientific judgment.
• Knowledge of GCP and Quality Assurance/Quality Control manufacturing procedures.
• Working knowledge of FDA’s 21st Century initiatives (e.g. Quality by Design)
• Experience in working with CROs, contract manufacturers and suppliers.
Compensation: 130k-150k
http://up.theladders.com/job/jobboard?pl=bj-U1&cr=1839839
