Director, WW Quality Systems
Job Description Summary=== ABOUT BD ===
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We support the heroes and heroines on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers.
ABOUT PHARMACEUTICAL SYSTEMS
With innovative pre-fillable syringes, self-injection systems, safety systems and needle technologies, the Pharmaceutical Systems Business Unit offers an extensive selection of solutions designed to protect, package and deliver drug therapies including vaccines.
Pharmaceutical Systems is one of the fastest growing businesses in BD, and in today's COVID world more than ever, we are so proud to enable our customers’ success with high quality and innovative drug delivery solutions that improve patient quality of life around the world!
Reporting to the VP Quality, Pharmaceutical Systems, the Director of Quality is responsible for the worldwide quality systems for all Pharmaceutical Systems manufacturing sites and design center locations. This highly cross-functional position oversees the continuous improvement and maintenance of a streamlined, practical, and effective quality system.
Working closely with business leaders, you will be responsible for being a true, strategic business partner and contributing to transformation initiatives that impact both the PS Business Unit, and our wider organisation!
You will also:
- Be a member of the Leadership Team for the Business Unit and contribute to the strategy, objectives, and implementation plans
- Be part of the Quality Systems leadership team and represent Pharmaceutical Systems for corporate quality system initiatives
- Keep abreast of a changing regulatory landscape, and maintain a compliant quality management system to meet existing regulations, changes to existing regulations, and new regulations
- Oversee Complaint Manager and ensures the complaints system is adequate for meeting internal and external customer expectations; build and present metrics; and ensure accurate investigations
- Supervise Quality Manager over Document Control, CAPA, and Training and is accountable for the adequacy and proper controls of the processes Oversees Change Control, and accurate documentation and communication of changes within the organization
- Manage the Global internal audit program, including internal auditors located in Pont de Claix
- Provide support for external audits, including tracking, trending, and providing support for closing audit non-conformances.
- Manage the risk management system for the product, process, and quality systems
- Drive solutions and lead positive change initiatives across functions and sites
We are looking for an experienced Quality leader, able to operate as a true strategic partner to our business. As well as Quality Management expertise, the successful candidate will possess strong leadership capabilities and be able to influence and inspire change.
You will have experience within a Manufacturing and R&D environment, within the Pharmaceutical or Medical Devices industry. You will possess knowledge of medical device regulations (including but not limited to ISO13485, 93/42/EEC 21CFR820) or pharmaceutical products (Eur GMP, 21CFR210/211).
Knowledge of combination devices is preferred, but not crucial.
Are you interested in working in one of the most exciting areas of BD in a strategic quality leadership role? If so, please hit APPLY!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationFRA Le Pont-de-Claix Cedex
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