Director of Quality Operations

TN United Kingdom; Cambridge; On-site; GBP 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Director of Quality Operations to lead and enhance quality assurance processes. This pivotal role involves strategic oversight of Quality Assurance, Document Control, and Supplier Management departments, ensuring compliance with cGMP, ICH, FDA, and ISO standards. The ideal candidate will possess extensive experience in the biopharmaceutical or medical device industry and demonstrate exceptional leadership skills to develop high-performing teams. Join a dynamic organization committed to excellence in quality operations and make a significant impact in the field.

Qualifications

• 14+ years of experience in Quality, with leadership experience.
• In-depth understanding of regulatory requirements in biopharma.

Responsibilities

• Provide strategic oversight for Quality Assurance and Document Control.
• Collaborate with teams to ensure product launches meet quality standards.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Communication Skills

Risk Management

Education

Bachelor's degree in a relevant field

Master's degree in a relevant field

Job description

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Director of Quality Operations, Cambridge

Client:

EPM Scientific

Location:

Cambridge, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

282638dd8fcd

Job Views:

42

Posted:

11.04.2025

Expiry Date:

26.05.2025

Job Description:

Key Responsibilities:

1. Provide strategic oversight and leadership for the Quality Assurance, Document Control, and Quality Supplier Management departments.
2. Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards.
3. Maintain and oversee a robust quality management system.
4. Collaborate effectively with cross-functional teams to ensure seamless product launches.
5. Proactively identify, assess, and mitigate quality risks.
6. Oversee the Quality Operations department, including 11 direct reports.

Qualifications:

1. Bachelor's degree in a relevant field, with a minimum of 14 years of experience (10+ years in Quality, 8+ years managing quality personnel). Alternatively, a Master's degree with a minimum of 12 years of experience (10+ years in Quality, 8+ years managing quality personnel) is acceptable. Prior leadership experience is essential.
2. In-depth understanding of regulatory requirements for the biopharmaceutical and/or medical device industry.
3. Excellent written and verbal communication skills.
4. Demonstrated ability to lead and develop a high-performing team.

Preferred Qualifications:

1. Prior experience in the medical device or biotechnology industry (biologics).
2. Internal and external quality audit oversight.