ASSOCIATE DIRECTOR, QUALITY COMPLIANCE Job in Waltham 02451, Massachusetts Us
General Scope and Summary Lead and manage all aspects of quality compliance for cGMP, GLP, and cGCP activities supporting the early development of targeted proteins called Adnectins.
Roles and Responsibilities
• Maintain company Quality-related documentation system (e.g., SOPs, documentation management)
• Core member of CMC teams to strategize and execute plans for the early development (IND to FIH) of Adnectins across a range of therapeutics areas
• Interact with external vendors to assess product failures and to assure corrective and preventative actions are implemented and investigations appropriately performed and documented
• Analytical data review and responsibility for release of drug substance and drug product
• Quality assurance oversight on site GLP activities
• Provide guidance on GMP issues and insight into production issues, interpretation of the regulations and maintain awareness of industry trends as they apply to the production of Adnectins and biologics
Experience, Education, and Specialized Knowledge and Skills
• BS minimum with 10 years of experience in the biotechnology/pharmaceutical industry with a focus on biologics; familiarity with health authority expectations for biologics
• Excellent communication, presentation, and interpersonal skills. • Ability to lead cooperatively in a matrix environment, as well as in the functional line setting, with a proven record as a team player. • Knowledge of the drug development process, laws,and regulations affecting the biotechnology/pharmaceutical industry.
• Excellent organizational skills, with an established ability to prioritize and manage multiple tasks simultaneously.
• Results oriented and have a strong track record of delivering against challenging commitments
• Embrace our core values: Challenge ourselves to excel: Seek and act to achieve the best outcome; Make and keep commitments; Create extraordinary experiences