Associate Director Quality Assurance - GMP and GDP
ProClinical is seeking an Associate Director Quality Assurance for a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious and life-threatening diseases. The associate Director Quality and Compliance In-Market Cluster will be based in Cham, Switzerland, the Associate Director Quality and Compliance In-Market Cluster reports into the Lead Quality and Compliance In-Market EMEA AP. The Quality and Compliance Person is responsible for ensuring that a quality management system is implemented and maintained for the distribution activities with BMS products in the identified Markets in EMEA AP.
- Lead and influence a dynamic and diverse staff of Quality professionals in distribution and ensure the proper skill set and development for the team aligned with BMS strategic.
- Lead the implementation of the Quality Management system, including the organization and the documentation and tracking the completion milestones.
- Deal with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
- Influence and affect the organization by communicating quality issues and decisions which impact the business.
- Ensure compliance of Distribution partners to all BMS requirements including distribution and transportation.
- Ensures continuous improvement activities for more effective Quality systems across the organization.
- Active participation to company business growth objectives for Quality alignment.
- Develop, implement and maintain the system for Distribution Suppliers qualification and management.
- Harmonized practices between the Distribution partners and ensure that BMS and local HA requirements are included in the Quality Agreement and observed.
- Handle compliance/quality issues with the impacted Distribution partners, liaise with the global functions.
- Attend the fact finding when required and define the adequate action plans in the Cluster.
- Coordinating the recall operations and mock recalls in the Cluster.
- Coordination of Quality Risk Management.
- Ensure that a Quality Management System is implemented and maintained in the local entities in the Cluster.
Skills and Requirements:
- Bachelor in Life Science required / tertiary qualifications, with knowledge in pharmaceutical sciences, Chemistry, Biology and/or Medicine is preferred.
- 10 - 15 years of progressive managerial experience within the quality assurance function of the pharmaceutical health care industry or regulatory agencies.
- Extensive knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential.
- Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies.
- Strong negotiating skills for interface with regulators and external Quality Assurance business. Demonstrated ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives.
- Understanding of the drug development process from discovery to marketing.
- Knowledge of how pharmaceutical products are marketed and the regulatory impact on promotional literature and activities.
- Demonstrate ability to switch priorities plus manage more than one project at a time. Ability to plan and conduct projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.
- Proven ability to influence, collaborate and communicate directly and to lead cross functional and cross regional teams.
- Good verbal, written and presentation skills in English; the ability to deal effectively with all levels of management.
- Willingness to travel up to 40% to the countries in the Cluster.
- BMS BioPharma Behaviors required
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 Courtney Russell on +44 203 8141 315 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.