West Pharma Quality Manager 

Ireland, Dublin 

867237972

Job Summary:

Reporting toDirector of Quality to ensure that all pharmaceutical products manufactured or distributed by the company comply with global and local regulatory requirements, company standards, and customer expectations.

Key Responsibilities:

Quality Systems Management:

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with GMP, regulatory requirements, and company policies.
• Oversee the management of SOPs, Work Instructions, and other quality-related documentation.

Regulatory Compliance:

• Ensure that all products and processes comply with relevant regulations and guidelines (e.g., FDA, EMA, MHRA).
• Stay updated with changes in regulatory requirements and ensure timely implementation of necessary changes.

Audits and Inspections:

• Lead internal audits and participate in external audits and regulatory inspections.
• Prepare audit reports, manage corrective and preventive actions (CAPAs), and follow up on audit findings.

Training and Development:

• Develop and execute training programs for staff on quality-related topics to ensure compliance with regulatory requirements and company standards.
• Monitor the effectiveness of training programs and maintain training records.

Quality Control:

• Oversee the quality control processes, including raw material testing, in-process monitoring, and final product testing.
• Ensure that all quality control activities are documented and carried out in accordance with established procedures.

Deviation and Change Control Management:

• Manage and investigate deviations, non-conformances, and product complaints.
• Oversee the change control process to ensure proper evaluation, approval, and implementation of changes in procedures, equipment, or processes.

Product Release:

• Collaborate with the Qualified Person (QP) to ensure that batch documentation is reviewed, and products are released in compliance with regulatory requirements and company standards.

Continuous Improvement:

• Promote a culture of continuous improvement by identifying areas for improvement and implementing effective solutions.
• Use quality metrics and data analysis to drive process improvements and enhance product quality.

Supplier Quality Management:

• Evaluate and qualify suppliers and contractors to ensure they meet the company’s quality standards.
• Manage supplier audits and assessments to maintain a high level of quality throughout the supply chain.

Required Qualifications:

• Bachelor's degree or higher in Pharmacy, Chemistry, Biology, or a related field.
• A minimum of 5 years of experience in quality management within the pharmaceutical industry.
• In-depth knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.
• Experience with QMS implementation and management.

Skills and Competencies:

• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.
• Attention to detail and strong analytical skills.
• Ability to handle multiple tasks and prioritize effectively.
• Proficiency in risk management and problem-solving.
• Competency in using quality management software and tools.

Preferred Qualifications:

• Certification in quality management (e.g., Certified Quality Auditor (CQA), Certified Quality Manager (CQM)).
• Experience with Lean, Six Sigma, or other continuous improvement methodologies.

Additional Information:

• Availability for travel as needed.
• Ability to work under pressure and meet tight deadlines.
• Commitment to maintaining the highest standards of quality and compliance.

Physical and Mental Requirements:

• Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
• Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.

Delegation of Duties:

When absent from the site duties and responsibilities will be delegated to the following designates:

• Senior Quality Engineer
• Quality Director