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Site quality director

Bray
beBeeQuality
Quality director
Posted: 14 July
Offer description

**Job Title:** Site Quality Leader

**About the Role:

The Site Quality Leader plays a pivotal role in spearheading the Quality function at our facility. This individual is responsible for overseeing the implementation, maintenance, and effective operation of Quality Systems that adhere to ICH Q10 compliance standards.

This position involves driving permanent inspection readiness through strategic planning, execution, and control of site Quality Systems, ensuring QA oversight for plant capital projects, including equipment qualification, IT tools, utilities, and facilities.

As a key member of the Site Leadership Team, this role fosters collaboration and inclusion across departments, driving excellence in compliance, supply, strategy, and cost.

The Site Quality Leader bears ultimate responsibility for API batch release, ensuring all batches meet current EU and FDA GMP directives and relevant marketing authorizations.

**Key Responsibilities:**

- Assess product introductions and major capital projects for Quality and validation considerations.

- Collaborate with site and global functions to ensure compliant, on-time projects (where applicable) and commercial supply of product to the network.

- Establish and maintain an effective Quality organization managing Quality Systems, Method Validation, Analytical Testing, Registration, and Batch Release.

- Lead the development of compliant, robust, and lean Quality Management Systems aligned with ICH Q1, Q7 Q10, regulatory requirements.

- Recruit, train, and appraise Quality management staff, ensuring ongoing development and succession planning.

- Implement governance systems to monitor process performance and product quality, assuring continued capability and suitability.

- Drive continuous improvement initiatives to enhance compliance, quality systems, and product lifecycle performance.

- Communicate new GMP compliance standards to the site.

- Represent the site during external GMP audits and regulatory inspections.

- Partner with site leadership to integrate Quality with other operational areas effectively.

- Ensure all API production complies with cGMP and applicable quality regulations.

- Make final decisions on non-routine batch dispositions.

- Liaise with Quality, supply organizations, and customers on significant product supply issues.

- Develop and manage the annual Quality department operating plan and budget.

- Represent the site in corporate and industry Quality forums.

- Promote a strong quality and compliance culture across the site.

- Lead Safety Compliance within Quality and Laboratory functions.

- Investigate incidents and implement preventative actions as required.

Requirements:

- Undergraduate degree in pharmaceutical, biological or chemical sciences.

- Relevant advanced degree preferred.

- Training & Experience at application of Change Execution Methodology.

- Recognised Lean Six Sigma Qualification (Yellow Belt, Green Belt or Black Belt).

- 10 years' experience, including significant management roles, in a pharmaceutical/veterinary manufacturing environment.

- Comprehensive knowledge of world-wide GMP regulations and expectations governing facilities, equipment and procedures for the manufacture and control of APIs as per ICH Q7.

- Proven track record of making quality and compliance decisions, applying sound scientific & regulatory judgment.

- Demonstrated experience of leading and driving results in continuous improvement projects.

- In-depth knowledge of GMP validation standards and systems.

- Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level.

Benefits:

We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense.

Our award-winning culture focuses on our colleagues' careers, connection and support.

We foster a culture of partnership and inclusion across departments.

How to Apply:

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