Job Description

Quality Assurance Manager

Are you an experienced Quality leader with a strong background in aseptic manufacturing and regulatory compliance?

Do you have the expertise to ensure inspection readiness and drive continuous improvement in a highly regulated environment?

Are you ready to lead a team and oversee key quality functions in aseptic pharmaceutical manufacturing?

Fraser Dove International is partnering exclusively with a leading pharmaceutical organisation. Operating in the US, they are committed to delivering high-quality healthcare solutions through innovation, compliance, and excellence in aseptic manufacturing.

Your objectives:

As the Quality Assurance Manager, you will be measured against the following objectives:

1. Lead and manage the Quality Assurance department, ensuring adherence to FDA, ISO, and other regulatory standards, particularly within aseptic processing environments.
2. Maintain site inspection readiness, overseeing compliance initiatives and driving a culture of sterile manufacturing excellence.
3. Develop and oversee key quality programs, including complaints, supplier quality, training, documentation, audits, and change control, with a focus on aseptic techniques and sterile processes.

What you will do:

As the Quality Assurance Manager, your duties and responsibilities will include:

· Manage and lead the Quality Assurance team, including supervisors and staff.

· Ensure the site remains in a state of regulatory inspection readiness, with a particular focus on aseptic operations.

· Oversee the customer complaint system, ensuring timely investigation and resolution.

· Lead the site training program, ensuring compliance with regulatory and corporate requirements, including GMP aseptic training.

· Ensure timely completion of Annual Product Reviews.

· Lead and manage the internal audit program, with an emphasis on aseptic compliance and sterile environment monitoring.

· Oversee the Change Control program to ensure compliance and effective change implementation.

· Drive Supplier Quality excellence to maintain high standards and continuous supply.

· Supervise incoming quality inspections and raw material/component release, ensuring aseptic integrity of materials.

· Manage the Document Control team, ensuring accuracy and compliance.

· Allocate and oversee departmental human and financial resources to meet performance goals.

· Ensure compliance with FDA, OSHA, ISO, and GMP regulations, with a strong focus on aseptic processing requirements.

What you will bring:

· Bachelor’s Degree in Engineering, Biological Science, or Chemical Science (or equivalent experience).

· Minimum 5 years of experience in a pharmaceutical or medical device GMP environment.

· At least 5 years of supervisory/management experience.

· Strong knowledge of pharmaceutical manufacturing, Good Manufacturing Practices, and aseptic processing.

· Proven experience working in aseptic or sterile manufacturing environments with an understanding of contamination control strategies.

· Ability to read, write, and communicate effectively in English.

Got what it takes?

To apply for the Quality Assurance Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Rachel Sampson – on +44 (0)203 355 7050.

Please Note:

· This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.

· If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.

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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices that transform and save patient lives.

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