Senior Quality Manager - Product Compliance
Our client is a rapidly growing pharmaceutical company with headquarters in Central London. They are currently seeking a Senior Quality Manager to lead their Product Compliance group. Reporting to the Quality Director, the Senior Quality Manager will have direct line management of up three Quality staff and will be responsible for the quality compliance of assigned products, globally, within contract manufacturers. You will ensure that products sold by the company are manufactured, packaged, tested and released efficiently and in compliance with applicable quality and regulatory standards. The role will require some international travel to suppliers / contract manufactures.
- Management of the quality team responsible for product quality and compliance
- Establish a close working relationship with the Contact Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products.
- Overall responsibility for the quality compliance of assigned products manufactured at Contract Manufacturers through:
- Creation and Maintenance of Quality / Technical Agreements
- Support of on-site audits and visits.
- Ensuring product quality reviews and stability studies are completed and assessed
- Ensuring products comply with applicable regulations, general and product monographs of applicable pharmacopeias.
- Ensuring CMO's are supplied and adhere to Compliance Files / Marketing Authorisations
- Quality approval of artwork
- Assessment and approval of deviations
- Managing and approval of change controls
- Investigation and resolution of complaints with CMO's
- Determining and implementing robust CAPA's as required.
- Performing in-market release of assigned products.
- Appropriate use of risk assessments and justifications to provide pragmatic solutions.
- Support Technology Transfers for assigned products where required.
- Support on-site audits by Regulatory Authorities and, where required, Customers.
- Keep up to date with the latest Regulations and support their implementation
- Author and approval of Standard Operating Procedures
- Input to and support of the Quality Management Review process
Skills and Requirements:
- Extensive experience working in Quality Assurance within the Pharmaceutical industry.
- Broad experience of all key areas of Quality Assurance and Pharmaceutical Quality Management Systems.
- Experience of working with and managing contract manufactures / outsourced service providers
- Working Knowledge of the Pharmaceutical GxP regulations
- Experience of successfully leading and developing employees.
- Able to foster strong cross-functional relationships.
- Excellent influence, interpersonal, verbal and written communication skills.
- Able to respond positively to, and effectively implement, change.
- Strong analytical and investigative skills to proactively solve problems.
- Commercial / financial awareness
- Digitally Savvy
- A degree or equivalent in a relevant scientific subject
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Highly Competitive Salary
Foster City, California
At ProClinical, we are seeking an experienced individual to fill the role of Senior Quality Agreements Compliance Manager, based in Foster City, CA.
Our client is a rapidly growing pharmaceutical company with headquarters in Central London.