Sr. Manager, Quality Engineering
We are seeking a Senior Manager of Quality Engineering candidate that would be responsible for managing and performing a wide variety of Quality Engineering activities in support of internal GMP activities for cell therapy products. The candidate is expected to provide Quality leadership for maintaining and enhancing, in a phase-appropriate manner, the quality and compliance aspects of our validation, calibration, change control, risk management, and facility maintenance programs. The successful candidate will report to the Director of Quality Assurance Operations in the company’s El Segundo, CA location.
Key Responsibilities Include:
- Independently review and approve equipment, facility, and instrument IQ/OQ/PQ and process validation protocols and reports.
- Independently review and approve Computer System Validation protocols and reports. GAMP 5 experience a plus.
- Assess validation, qualification and/or requalification, calibration, and maintenance requirements of all GMP equipment, instruments, and facilities in collaboration with equipment owners.
- Review, revise, and approve Standard Operation Procedures, study protocols, and reports.
- Perform risk analyses using tools such as, but not limited to, Hazard Analysis, FMEA, FTA, HACCP, etc.
- Perform or support CAPAs arising from engineering and validation issues. Perform root cause analysis with tools such as, but not limited to, Ishikawa, A3, 5 Whys, Is – Is not, DMAIC, etc.
- Manage and oversee the change control program for all GMP activities, facilities, equipment, and instruments.
- Perform statistical analysis, where appropriate and based on risk, to support various studies. Prior statistical software experience with Minitab, SAS, or JMP a plus.
- Will provide training to new personnel in areas of risk management, statistical process control, and change control.
- Participates in authoring complex, explicit documentation for cell therapy and other quality engineering documentation.
- Ability to organize and manage data relating to Quality Engineering activities.
- Provide status reports, including relevant quality metrics and participates in the management review process;
- Periodically conducts internal auditing activities to ensure that systems are operated in accordance with established SOPs and GMPs.
- Supports preparation for regulatory agency inspections and participates as a Subject Matter Expert during regulatory GMP inspections
- Provide quality assurance leadership, support, guidance and direction to internal manufacturing and quality teams operating under cGMP regulations
- Identify and support continuous improvement projects in collaboration with different functional group management to achieve quality, reliability and efficiency improvement objectives.
- Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters are addressed in an open and timely manner.
- Actively manages department and site goals and objectives.
- Performs other duties as assigned.
- BS or advanced degree in Engineering, Biomedical Engineering, Chemical Engineering, Biotechnology or equivalent science degree.
- Minimum 6-8 years of experience in the pharmaceutical / biopharmaceutical industry and 2-3 years direct experience managing Quality Engineering
- Good knowledge of biologics cGMP manufacturing including ideally recombinant protein and cell therapy cGMP manufacturing.
- Proven management skills with ability to build a high performing team and lead others effectively.
- Excellent verbal, written, and interpersonal communication skills.
- Proficiency in computer use and Microsoft Office applications.
- Proven ability to work independently and analyze and resolve issues that impact quality.
- Attention to detail with strong analytical and problem solving skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities.
- Exceptional organization, flexibility, and time-management skills. Ability to deliver under deadlines.
- Strong audit and investigation skills.
- Must be able to gown and perform activities in a cleanroom environment under aseptic conditions.
- Familiarity with risk management activities per ISO14971 or ICH Q9 is desired.
- Statistical Process Control (SPC) or Six Sigma experience is desired.
- Experience in supporting an FDA inspection is desired.
- Experience in aseptic processing is desired.
- Basic lab skill knowledge (cell culture, pipetting, dilutions, titrations, etc.) is desired.
*all hires are based upon successful completion of background check