Sr. Director – GMP Quality Operations

We are looking for Sr. Director of GMP Quality Operations with expertise in current Good Manufacturing Practices (GMP) and relevant regulations. The successful candidate will be working closely with the CMC leadership and support the clinical and research teams to ensure oversight of manufacturing operations.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Act as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and analytical controls.
• Lead the implementation of GMP activities as required by internal procedures and application of regulatory requirements.
• Lead and support activities related to external quality such as, but not limited to, development of process and analytical methods, tech transfers, deviations/investigations, quality agreements, lot dispositions, supplier and contract manufacturing selection and qualifications.
• Lead management and product review meetings. Provide quality oversight of key CMC and IND enabling documents. Review and verify process data to assure compliance with data integrity.
• Oversee the Quality System unit development and management. Drive process and product quality through effective quality systems and supplier oversight/surveillance
• Represent Quality on project teams, Health Authority Inspections, suppliers and CDMO operational meetings, and QA to QA meetings.
  
   

EDUCATION & EXPERIENCE

• Bachelors or advanced degree in Biology, Chemistry, Chemical Engineering or related field.
• Minimum 15 years of GMP Quality Assurance experience.
• Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.

KNOWLEDGE/ SKILLS/ ABILITIES

• Ability to make timely and sound quality decisions when faced with complex supply, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Hands-on experience in manufacturing and/or analytical testing & development.
• A successful track record working with suppliers and CDMOs.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
• Understanding of QP requirements and processes a plus.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities with cross-functional teams.
• Some travel required.