Want to join a growing biopharmaceutical manufacturing organization that's rapidly expanding? See the below for more information!
Overview: The Manager, Quality Manufacturing oversees daily product manufacturing and lot release, acting as the primary Quality contact for internal teams. This role ensures all products meet regulatory, corporate, and customer standards for quality, safety, and efficacy.
Key Responsibilities:
- Lead Manufacturing Quality Assurance activities, including batch record reviews and 24/7 oversight of manufacturing processes.
- Address quality queries from QA and Production teams.
- Provide technical expertise and training on cGMPs.
- Support validation report closure, change control, and other QA systems.
- Manage strategic projects and collaborate with plant management on new products and changes.
- Drive quality and compliance improvements using current regulations and best practices.
- Hire, train, and develop MQA staff, conducting performance reviews.
- Develop and support departmental goals for quality standards and regulatory compliance.
- Serve as the QA expert for product release, inspections, batch record reviews, and compliance.
- Ensure SOP compliance and maintain up-to-date training.
- Perform other duties as assigned.
Key Qualifications:
- BA/BS degree in Chemistry, Biology, Computer Science, Engineering, or a science related field, as applicable.
- Requires a minimum of 7 years of Quality Assurance experience in a GMP regulated environment, contract manufacturing experience preferred.
- A minimum of 2 years of management/leadership experience is required including manufacturing oversight experience.
- Must have experience working in an aseptic or sterile facility.
