Senior Director, Global Quality for a worldwide healthcare company with expertise in medical products, pharmaceuticals and biotechnology.
Position Overview: This position will direct and manage global quality initiatives supporting medical products such as intravenous solutions and admin sets, premixed drugs, and drug systems, pre-filled vials and syringes for injectable drugs, IV nutrition products, infusion pumps, inhalation anesthetics and products and services for kidney dialysis.
The company’s quality system is deployed globally which enables the design, development, manufacturing, packaging, sterilization, labeling and distribution of company products to ensure they conform to customer requirements. To improve the quality system, the company ensures that various measurements, monitoring and analysis methods such as management reviews, internal, external and vendor audits are employed at all levels. Products are required to meet specific quality standards, both in packaging and in product integrity and quality.
Reporting to the VP of Global Quality will direct and manage the team responsible for execution of the quality system within the development and sustaining programs supporting all Medical Products
- Establish, implement and maintain systems, procedures and policies regarding quality of product, records, and data for R&D
- Manage overall coaching, training, development and succession plans for the quality team to include three Directors of quality
- Provide QC/QA input to Management with a view towards compliance with Federal Regulations and company requirements
- Ensure that appropriate quality systems exist at every R&D facility globally regarding cGMP compliance through audits and organizational structure
- Ensure all operations are in accordance with applicable CQPs (corporate quality programs) and SOPs
- Influence and establish necessary policies and systems to ensure the development, maintenance and enhancement of the Product Development process comply with all regulatory requirements
- Ensure compliance to specification and applicable regulations emphasizing prevention rather than correction and minimize risks in all areas of Research and Development activities
- Identify long-term quality objectives for R&D and translates into specific actionable annual objectives
- Determine quality resources necessary to meet strategic objectives
- Advise top management about quality concerns and makes recommendations for improvement
- A record of success working with multifunctional global teams
- Proven track record of effective deployment and execution of quality strategy and systems for Design Control
- In-depth knowledge of cGMPs and applicable federal, state and local regulations for manufacture of medical products
- Deep understanding of risk management processes, design methodologies, design transfer and scale up activities required.
- Capable of independent decisions and knowledgeable as to when a multi-disciplinary application is needed for decision-making
- A rounded business perspective that will provide input on new products and on acquisition, licensing, joint venture and other business decisions Strong leadership, managerial and communication skills are required
- BS degree in science or engineering; advanced degree helpful
- Minimum of 10 years experience in cGMP Quality, Manufacturing or related field in the medical products/pharmaceutical industry
- 7 years of line management experience in cGMP quality, preferably in support of R&D; and is currently at the Director/Sr. Director level
For information contact: Tanner & Assoc, Executive Search Consultants, 760 598 3363 email@example.com