Senior Director Quality Manufacturing

Fraser Dove International; Maine; On-site; USD 75,000 - 229,000; Full time

Job summary

A leading Life Sciences organization is seeking a Senior Director of Quality Manufacturing in Maine. The role involves strategic leadership in Quality Assurance and Compliance, ensuring regulatory adherence, and fostering a high-performing team. Ideal candidates will have extensive experience in biotech and a strong educational background in relevant sciences.

Qualifications

• 10+ years in pharmaceutical or vaccine/biotech production with increasing Quality responsibilities.
• 5+ years of people management experience.

Responsibilities

• Lead all Product Quality, Compliance, and Quality System activities.
• Drive inspection readiness and regulatory compliance.
• Build and develop a high-performing Quality organisation.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Conflict Resolution

Strategic Thinking

Education

Bachelor’s degree in biochemistry, chemistry, virology, biology

Advanced degree preferred

Job description

1 week ago Be among the first 25 applicants

Direct message the job poster from Fraser Dove International

Associate Director / Life Sciences / Executive Search / Biologics / Biotech / Pharmaceuticals / VC / PE / Quality & Regulatory

Senior Director Quality Manufacturing

Are you a seasoned Quality leader with Biotech expertise ready to drive strategic transformation?

Can you lead Quality teams through complex regulatory landscapes while ensuring operational excellence?

Do you thrive in a leadership role where innovation, compliance, and cross-functional collaboration intersect?

Fraser Dove International is partnering exclusively with a leading Life Sciences organisation.

Operating globally, they are committed to advancing the health of people, the planet and the enterprise through sustainable innovation.

Our client is seeking a visionary leader to spearhead Quality Assurance, Compliance and Control activities at a flagship US manufacturing site.

Discover more about our Senior Director Quality Manufacturing opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Senior Director Quality Manufacturing, you will be measured against the following objectives:

• Lead all Product Quality, Compliance, and Quality System activities at the Maine site.
• Drive inspection readiness and regulatory compliance, serving as site lead during external audits.
• Build and develop a high-performing Quality organisation, with succession planning and talent development at its core.

What you will do:

As the Head of Senior Director Quality Manufacturing, your duties and responsibilities will

include:

· Provide strategic leadership across Quality Assurance, Compliance and Control functions.

· Ensure regulatory compliance with FDA, and global regulatory requirements.

· Lead site readiness and representation during all regulatory inspections and audits.

· Oversee product testing, validation, and release processes in line with cGMP.

· Direct and develop a team of 6 managers and a wider group of 40 Quality professionals.

· Drive continuous improvement through a robust and future-focused Quality Plan.

· Collaborate with cross-functional teams to support product development and commercialization.

What you will bring:

These are the skills and experience you will need to succeed as the Senior Director Quality Manufacturing:

· 10+ years in pharmaceutical or vaccine/biotech production with increasing Quality responsibilities.

· 5+ years of people management experience, including direct and indirect reports.

· Deep knowledge of cGMP and regulatory standards, including FDA, and EMEA.

· Versatility in conflict resolution and cross-functional leadership.

· Sound strategic and business acumen.

· Bachelor’s degree in biochemistry, chemistry, virology, biology or a related scientific field.

· Advanced degree preferred but not required.

What you will get:

These are the perks and benefits that will complement your generous base salary:

Got what it takes?

To apply for the Senior Director Quality Manufacturing, click the ‘Apply’ button below

or contact the Executive Search Consultant – [Peter Vedde] – on [phone].

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.

· We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Science, and Manufacturing

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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