About the job:
We are looking for a Quality Assurance Director to support establishment of a new cGMP manufacturing facility for clinical supplies (Phase 1 and 2 studies) for pharmaceutical and biotech clients in the ADC and small molecules space.
- Participate in the design and planning for GMP manufacturing suites, utilities, and other aspects of the new facility
- Establish phase appropriate quality systems to support clinical phase manufacturing of small molecule APIs, antibody-drug conjugate (ADC) drug substances, and ADC drug product
- Ensure that all applicable Quality guidelines and regulations are followed, as appropriate for each product development phase or commercial stage
- Develop department organizational, resource planning, and continuous improvement strategy
- Manage QA professionals assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs, goal setting, and performance management in accordance with the company's HR policies, in order to ensure all QA professionals are aligned and motivated towards achieving the company's goals, values and culture by promoting their personal and professional development while maximizing productivity
- Oversee all QA organization in the Site under his/her responsibility to assure that all applicable procedures, established objectives are followed and achieved
- Act as a senior management representative in meetings with clients, vendors, and regulatory agencies
- Review and approve critical quality documents
- Review and approve of quality documents, CofA's for release materials & stability samples in GMP.
- Oversee administration of GMP and non-GMP documents and training in the electronic document management system
- Train all employees in cGMPs
- Execute internal audits and audits to vendors and external clients according to the established plans, needs and the criticality of the audits; provide overviews of audit findings for presentation to management as required and respond to the client audits.
- Manage the CAPA, change control, deviation, and risk assessment programs
- Work closely with GMP Manufacturing, Quality Control, Facilities, and Supply Chain leadership to ensure that manufacturing, laboratory, facilities, and materials operations are conducted in compliance with current Good Manufacturing Practices (cGMP).
- Stay abreast of regulatory and compliance requirements to ensure the company remains compliant with all applicable laws and guidelines
- Oversee environmental monitoring in GMP manufacturing facility
- Responsible for final disposition of raw materials, intermediates, API/DS batches, and DP batches
- Create an environment where continuous improvement is part of the teams' activities and drive for the simplification of procedures and daily tasks
- Create a culture of safety, quality, and compliance. Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice
Knowledge, Skills, and Abilities
- Have experience to manage and lead a Quality Assurance department
- Experience with manufacturing, laboratory, facilities, and materials operations in compliance with current Good Manufacturing Practices (cGMP) and global regulatory authority requirements.
- Must possess excellent oral and written communication skills
- BS, MS, or PhD degree in chemistry, biology, biochemistry, microbiology, or related discipline
- 10+ years of experience in a GMP manufacturing or CRO setting