Head Of Quality / Senior Quality Manager – Sterile Manufacturing

Head of Quality / Senior Quality Manager (Sterile Manufacturing Environment)

Are you a seasoned Quality professional with extensive experience in a Sterile Manufacturing environment? Our client, an innovative vaccine manufacturer, is seeking a dynamic Head of Quality / Senior Quality Manager to join their team. This is a critical role aimed at maintaining and enhancing the highest standards of Quality in their production facilities. The ideal candidate will have a significant amount of Quality leadership experience. 

Key Responsibilities:

Leadership:

• Contribute to the overall company strategy, aligning with organisational goals.
• Design and implement quality strategies prioritising product delivery timelines.
• Provide mentorship and leadership to the Quality team, fostering a culture of excellence.
• Coordinate and delegate responsibilities within the Quality team to ensure efficient operations.
• Encourage and facilitate cross-functional collaboration to enhance quality outcomes.

Management:

• Oversee the company’s Quality System, ensuring compliance with GMP manufacturing and release processes.
• Manage relationships with external stakeholders to ensure quality standards are met.
• Identify and resolve quality issues, taking a proactive leadership role in addressing complex problems.
• Implement new processes and programs for continuous quality improvement.
• Enhance business efficiency through rigorous quality system management.
• Maintain and update the Quality System to ensure ongoing performance and integrity.
• Prepare, review, and authorise master documents.
• Ensure proper final release of goods, adhering to defined quality control procedures and specifications.
• Maintain preventative maintenance schedules for critical instrument calibration and validation activities.
• Collaborate with Production and other departments to investigate and resolve OOS, deviations, product complaints, and recalls.
• Enact necessary change controls for procedural or process improvements.
• Facilitate continuous training on Quality-related issues across various departments, including Production, R&D, Regulatory, and Quality.
• Lead audits conducted by the regulators. 

Documentation:

• Ensure all documentation meets company and relevant quality standards.

Work Health & Safety (WH&S):

• Adhere to Work Health & Safety legislation and company policies.
• Demonstrate a commitment to WH&S through active personal involvement.
• Take reasonable care to protect personal safety and the safety of others in the workplace.
• Follow reasonable health and safety instructions and participate in WH&S education and training.
• Report any workplace hazards promptly.

Qualifications:

• Extensive experience in a quality role within a Sterile Manufacturing environment, preferably in vaccine production.
• Proven track record in managing GMP quality systems and leading quality teams.
• Strong leadership skills with the ability to mentor and develop team members.
• Excellent problem-solving skills and the ability to manage complex issues effectively.
• Experience with regulatory audits and maintaining compliance with industry standards.

Our client offers a competitive salary, comprehensive benefits, and a supportive work environment that values innovation and quality. If you are passionate about making a difference in the field of vaccine manufacturing and have the skills and experience to excel in this role, we would love to hear from you.

To apply, please submit your resume and a cover letter detailing your relevant experience and why you are the ideal candidate for this position.

Apply For This Role Include a message to the recruiters. Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.Please use a file name shorter than 100 characters. Attach a cover letter file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.Please use a file name shorter than 100 characters.

Share this with a colleague or friend!