Quality Control Manager
Company Summary: A small clinical-stage biopharmaceutical company, specializing in injectable products, is currently seeking a driven, motivated, and multi-faceted Quality Control Manager. This role will be located in the greater RTP, NC area. The Quality Control Manager will play a critical role in ensuring the quality and compliance of biologics products through the development, implementation, and oversight of quality control systems and processes.
The Manager will be responsible for:
- Develop, implement, and maintain robust quality control systems to ensure compliance with regulatory requirements and industry standards (including FDA regulations and cGMP guidelines).
- Oversee all aspects of quality control activities related to biologics biopharmaceutical manufacturing, including raw materials testing, in-process testing, and finished product testing.
- Establish and maintain appropriate quality control documentation, including standard operating procedures (SOPs), protocols, and reports.
- Provide leadership and guidance to the quality control laboratory team, ensuring that testing activities are conducted accurately, efficiently, and in accordance with established procedures.
- Lead investigations into deviations, out-of-specification results, and non-conformances, implementing corrective and preventive actions as necessary.
- Provide quality control expertise and guidance to cross-functional teams, ensuring alignment with quality objectives and regulatory requirements.
The Manager should have the following qualifications:
- Bachelor's degree in Chemistry (or related field)
- Minimum of 5 years of experience in quality control within the biologics biopharmaceutical industry, with at least 2 years in a leadership or managerial role.
- Strong understanding of regulatory requirements and quality standards applicable to biologics manufacturing (e.g., FDA regulations, cGMP guidelines).
- Proven track record of effectively managing quality control systems and laboratory operations in a biopharmaceutical setting.
- Prior experience working with the injectables dosage form.
Benefits:
- Health, vision, and dental benefits
- Annual holiday bonus
- Dynamic, fast-paced, and collaborative work environment
If you see yourself in this Manager role and are interested, then please don't wait to apply.
