TriLink Biotechnologies is seeking a Senior Manager, Quality Operations responsible for leading all aspects of the Quality Operations function, including product release, approval of deviations and non-conformances, validation, design control/transfer, and hosting external customer audits. Be the quality point of contact for GMP custom product manufacturing for Drug Substance/API customers. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations. Responsibilities include:
- Lead the quality operations team for approval and release of raw materials and finished good products (e.g. research grade reagent products and Drug Substances/APIs).
- Work with GMP team (manufacturing, QC, commercial) and customers on defining customer requirements for GMP custom products (e.g. API's for clinical use). Be the quality point of contact for GMP custom product manufacturing.
- Review and approve quality agreements, custom product project orders, and other customer contracts containing quality related information.
- Approve master and executed batch records including final product disposition. Review and approve deviations and non-conformances prior to product release.
- Prepare, review, and/or approve validation protocols and reports related to quality operations.
- Lead cross-functional teams in risk identification and mitigation activities during risk management process.
- Provide quality oversight for design control and design transfer activities.
- Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and effectiveness. Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
- Lead and/or support external quality audits (e.g. customers, ISO, etc.).
- Develop, maintain, and communicate quality metrics to ensure visibility of QMS health.
- Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to develop, implement, and continuously improve the Quality Management System.
- Manage subordinate employees, including training, employee development, and performance management.
- Perform other duties, as assigned.
- Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
- Quality professional with a minimum of 8 years relevant experience in a life science industry.
- Minimum of 5 years of leadership experience.
- Requires knowledge of cGMPs regulations (e.g. 21 CFR 210, 211 or 21 CFR 820), ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients (API), and ISO 9001 (or ISO 13485) regulations.
- Familiar with cleanroom operations (e.g. operating in a cleanroom, EM monitoring, validation, etc.)
- Strong and effective verbal and written communication skills.
- Strong interpersonal, teamwork and customer interfacing skills.
- Strong problem-solving skills and analytical skills applied to investigations.
- Self-motivated and able to organize and prioritize multiple tasks.
- Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
- Experience in supporting inspection readiness activities resulting in successful inspections.
TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
TriLink is an EEO employer.