The Manager of Quality Control is responsible for designing, planning, implementing, and evaluating a quality Control function which support analytical development and regulatory approval of products. This role requires extensive interaction with Pharmaceutical Operations, Quality Assurance, Quality Operations, Program and CMC project management, Regulatory Affairs, and CMOs.
- Develop, implement, maintain and continually assess a quality control function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to, the following tasks:
- Plan and coordinate all the analytical R&D and quality control activities.
- Establish robust analytical development strategies.
- Generate release and stability specifications for raw materials, drug substances and drug products.
- Manage method development and method validation activities for drug substances, intermediates and finished drug products.
- Review stability study design, monitoring, reporting and data trend-analysis.
- Perform clinical material evaluation and COA generation.
- Manage method transfer activities to contract manufacturing organizations/testing laboratories.
- Write/review/approve, methods, protocols, validation reports etc.
- Write/review/approve deviations and investigations at contract manufacturing organizations/testing laboratories.
- Establishing and maintaining a document control system for QC procedures, work instructions and forms.
- Ownership of test record review and COA creation.
- Contribute to Annual Product Reviews.
- Prepare and review analytical sections of CMC for regulatory submissions and annual reports
- Implementing, performing and overseeing internal quality auditing of QC function (including applicable vendors or subcontractors), customer quality audit response, and other QC related quality management system activities.
- Implement a continuous improvement plan for growing and maturing the quality control function and the quality management system, including the following tasks:
- Performing periodic internal quality control system reviews and audits
- Designing, developing, implementing and enforcing best practices, processes, guidelines, systems, and technology to support and enhance the quality control function and the quality management system.
- Maintain current knowledge base of regulations, corporate policies and standards to ensure that the quality control function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
- Support strategic planning by timely communicating Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
- Identify risks and assumptions in plans, anticipate problems and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.
- Bachelor's Degree is required (Chemistry, Biological sciences, Engineering or related degree); advanced degree is a plus.
- Minimum of 6 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
- Ideally a minimum of 3 years of experience in leading Analytical Development/Quality Control function, preferably at the Manager level.
- Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
- Management skills to grow and manage a high performing Quality organization.
- Demonstrated skills in project management and working with vendors and contractors
- Background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.
- Experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
- Excellent interpersonal skills, organizational skills, written and oral communication skills
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables
- Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.
- Must be available to work in the evenings and weekends, as required.
- Position is in the United States (Irvine, CA or Cambridge, MA)
- Position may require up to 20 % travel (or) occasional local travel