Head of Quality - Deputy
Are you ready to succeed the Head of Quality of one of Europe's largest manufacturing sites in 18 month?
Do you thrive in collaborative, innovation, and open cultures?
Are you able to build networks and effectively influence and partner with senior stakeholders to drive change?
Fraser Dove International is partnering exclusively with a leading Global Biopharmaceutical organisation. Operating in Germany, they are committed to manufacturing innovative products that advance patient care.
Our client is seeking a dynamic leader to oversee the Quality Assurance operations, driving compliance, employee development, and operational excellence at their flagship site.
Discover more about our Head of Quality & Operations opportunity; its objectives, duties / responsibilities, and the skills, experience, and competencies needed to succeed.
Your objectives :
As the Head of Quality & Operations, you will be measured against the following objectives :
- Continuously improve and optimise the Operations Quality systems to ensure compliance with cGMP and Medical Device regulations.
- Provide strategic Quality oversight, fostering alignment with corporate and regulatory standards while preparing for and leading regulatory inspections.
- Develop a high-performing Quality Assurance team, implementing effective succession planning, training, and employee development programs.
What you will do :
As the Head of Quality Assurance & Operations, your duties and responsibilities will include :
Lead the Quality Assurance department, managing resources and ensuring occupational safety compliance.Ensure continuous improvement of compliance processes and establish Quality-related priorities with high financial impact.Stay updated on industry trends, emerging regulations, and evolving authority expectations, implementing necessary Quality system changes.Oversee nonconformities, complaints, CAPA, change control, and other processes in compliance with corporate and regulatory requirements.Provide Quality oversight for qualification, validation projects, and APR / PQR within Ludwigshafen Operations.Drive inspection readiness, represent the site in audits and inspections, and manage relationships with regulatory authorities.Maintain the site’s authorization and manufacturing license, ensuring compliance with regulatory filings.Manage supplier qualification systems, ensuring timely qualification, monitoring, and control processes are in place.Oversee Quality risk management, data governance, batch record review, and other core Quality processes.Maintain an effective Operations training system and ensure appropriate employee training on department objectives.What you will bring :
These are the skills and experience you will need to succeed as the Head of Quality Assurance & Operations :
Strong leadership skills with significant experience managing large teams.At least five years of experience in Operations Quality Assurance within the pharmaceutical industry.Deep understanding of cGMP regulations (EU / US) and regulatory agency expectations.Proven track record of managing regulatory inspections and audits.Passion for performance, innovation, and a results-oriented approach to work.High self-motivation and excellent organizational skills.Exceptional communication and presentation abilities.Degree in Chemistry, Pharmacy, Biology, or a related scientific discipline.Minimum ten years of experience in the pharmaceutical industry, ideally with exposure to both drug products and APIs.Got what it takes?
To apply for the Head of Quality Assurance & Operations, click the ‘Apply’ button below or contact the Team Leader, TechOps and Quality – [Aidan Russell] – on +44 (0)203 355 7050.
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 authorized 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 /Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices which transform and save patient lives.
