The Quality Control Manager (QCM) assists in the planning and scheduling of QC and Analytical testing activities conducted at both contract testing laboratories (CTL) and in-house. The QCM will ensure that the laboratory operations and all records and procedures are cGMP compliant. This position involves mentoring two to five QC Associates/Sr. Associates at Sarepta. The QCM will provide guidance to both the CTL and internal direct reports. The QCM will collaborate with cross functional teams to establish project timelines and priorities, ensure QC deliverables and the timelines are met. He/she must exercise discretion and judgment in handling Sarepta’s confidential information. All work conducted in internal and external laboratories will meet FDA regulations, ICH guidelines and GLP regulations. This job requires exceptional organizational skills and excellent communication skills, as well as the ability to balance changing priorities and tight time lines.
Primary Responsibilities Include:
- Monitoring the progress of the internal and external QC deliverables. Ensure timelines are met.
- Review the release and stability data, as well as method validation/qualification protocols and reports conducted in-house and at the CTL.
- Assist in managing the method development, validation and routine testing activities at the CTL. Ensure timelines are met.
- Manage the QC laboratory activities at Sarepta Therapeutics Inc. Andover, MA site.
- Maintaining equipment and associated software in the laboratory in compliance with cGMP regulations.
- Acts as an advisor to provide routine guidance to both internal team and CTL to resolve technical problems.
- Provide technical support for internal and external investigations, deviations, CAPA and change control activities.
- Develop and deploy laboratory documents such as SOPs, laboratory protocols (development and validation).
- Maintain laboratory notebooks and other written documents following good documentation practices.
- Review analytical data and provide feedback to both external and internal teams. Assist in continuous improvement activities.
Education and Skills Requirement:
- Bachelor’s degree or Masters degree in life sciences in Chemistry, Biology preferred
- 6 - 8 years’ direct experience in GMP laboratory setting
- Demonstrate conceptual and theoretical knowledge in method development and method validation for Oligonucleotide and biologics analysis methods
- Demonstrates strong leadership abilities through direction, influence and personal action.
- Solid understanding of cGMP requirements. Experience in working in a cGMP location is highly desired.
- Highly skilled in operating Waters, Agilent and Thermo HPLC instruments and MS instrumentation is required.
- Strong computer skills including knowledge of Empower, ChemStation, Excel, Word and PowerPoint.
- Proven ability to work independently and effectively handle multiple priorities is a must.
- Ability to maintain confidentiality of proprietary information expected.
- A good team player that takes initiative to complete tasks diligently and correctly.
- Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
- Proficient written and verbal communication skills.
- Position may require some travel.