Careers that Change Lives
This position has responsibility for leading quality systems, operations quality and supplier quality acting as the Site Quality Leader and Management Representative for the Rice Creek, MN site. In addition, this position has oversite to the quality function at the Monmouth Junction, NJ site.
This position acts as liaison with Medtronic Business Units, Corporate, and CRHF (Cardiac Rhythm & Heart Failure) sister manufacturing facilities to drive quality management strategies and activities resulting in the highest level of product quality. Emphasis will be on continuous improvement of systems and the execution of site quality strategies through direct accountability and influence within the CRHF operations organization. This includes leading and managing CRHF-level quality projects across multiple manufacturing sites, including acting as the Chair of the Rice Creek and CRHF Supplier CAPA Boards.
This position provides leadership and resources to ensure compliance with all elements of the quality management system throughout the organization and ensuring quality system performance is measured and routinely reported to executive management.
A Day in the Life
• Develops and deploy Quality and Compliance strategies that are aligned Pharma & Combination Product regulations and with Medtronic’s business strategy across areas of responsibility • Reviews, directs and manages manufacturing and pharma QA strategies, organization, and execution for results. Ensures that approaches are innovative, industry leading, and meeting the needs of customers and CRHF business strategies. • Manages the Pharma Operations Analytical and Chemistry Laboratory.• Collaborate with Rice Creek and Monmouth Junction operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results.• Develops and maintains appropriate communications within and between CRHF and other businesses to deliver on Medtronic’s overall quality and operations needs worldwide, collaborating as appropriate to ensure synergies with and between organizations to leverage a harmonized approach whenever possible. • Proactively manages quality assurance and compliance activities in order to produce the highest quality products and prevent defects. • Creates a culture of continuous learning across areas of responsibilities where root causes on quality issues are identified and organizational learning is institutionalized. • Ensures effective processes are established within the organization to monitor quality and compliance execution. Implement proactive and preventive strategies for the resolution of quality and compliance opportunities. • Assures the processes used in the manufacturing of products are properly developed, characterized, qualified, and validated to assure the highest possible quality and to ensure an uninterrupted supply of quality product to meet the needs of our customers.• Assures that manufacturing quality and performance data are comprehensively measured, trended, reported, and acted on in a timely manner to ensure compliance and support continuous improvement. Ensures constant vigilance in line rejects, manufacturing related field returns of those products and changes to manufacturing process to assure the highest possible quality. • Creates a world class Quality organization ensuring top talent is hired, developed, and retained.• Lead the strategic planning efforts for area of responsibilities Annual Operation Plan (AOP).• Provide strategic direction and drive Supplier Quality risk reduction efforts (ie Go Green projects, etc)• Monitor and communicate SQ metric performance to Site Quality & Operations Leadership. • Ensure Supplier Control processes are embedded in daily site sustaining activities (ie supplier qualification, audit, change management, performance measurement and monitoring, periodic verification, sCAPA/CAPA)• Engage representation in the CVG Council for input and execution of the CVG Quality Strategy
Responsibilities may also include the following and other duties may be assigned
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Must Have: Minimum Requirements
• Bachelor's Degree in Engineering or Science Discipline + 10 years of relevant experience with 7+ years of people management experience• Previous leadership experience in a Pharma and/or Combo Product manufacturing environment• Minimum of 10 years of experience with increasing responsibility in Operations and/or Quality functions.• Minimum of 10 years of experience and knowledge of good manufacturing practices (GMP's) Global Quality Systems regulations, and ISO 13485
Nice to Have • Experience in medical or high reliability product industry highly preferred. • Experience in multiple Quality related functions is preferred• Experience in with ISO 17025 and an analytical lab environment• Highly results oriented and focused on business priorities. • Strong leadership and influencing skills to drive results in a highly matrixed organization. • Business and Quality perspective. • Strong change management and transformation skills. • Excellent Communication/Presentation Skills. • Excellent Interpersonal and Talent Management skills.• Supplier Controls process knowledge & experience