Vice President, Global Manufacturing Quality

Hologic's Quality team is seeking a Vice President, Global Manufacturing Quality supporting multiple Divisions with direct responsibility for all manufacturing and supplier (supply-chain) related quality activities. This role will also have direct or indirect responsibility for distribution quality. This leader will be responsible for ensuring medical devices and components are manufactured in accordance with 21CFR820, ISO13485 standards and division specifications while delivering high quality supply to customers globally. 

What We Expect: 

As the Vice President, Global Manufacturing Quality, you will be responsible for delivering worldclass performance related to supplier quality and manufacturing quality across several global sites serving multiple divisions. You will be expected to deliver innovation and strong processes around good manufacturing processes (cGMP), supplier quality and distribution quality (as needed). This role will establish operational, strategy objectives and work plans to deliver high quality supply.

Strategic Alignment

• Create, communicate and execute strategy for manufacturing quality team in alignment with Corporate and Divisional strategies 
• Manage supply chain quality driving proactive supplier development to ensure quality supply
• Responsibility for distribution quality (as needed)
• Prepare and execute operating and capital budgets which include resource requirements.
• Promote Culture of Quality throughout the organization.

Talent Management

• Build, develop and lead a global team focused on supply chain quality (supplier through manufacturing and distribution, as needed). Effectively manage headcount allocations for their organization
• Drive innovation and continuous improvement in supply chain processes to achieve operational excellence with the goal of improving on-time quality supply for customers, globally 
• Motivate and manage teams for high engagement and performance.

Operational Excellence

• Work to deliver high quality products, meeting divisional specifications (prevent out of box failures) 
• Introduce innovative processes and best practices to improve quality in supply chain and deliver efficiencies in collaboration with operations, division and corporate quality partners (including supporting VIP projects as necessary)
• Track, report and lead initiatives to drive down Cost of Poor Quality in manufacturing 
• Work with commercial businesses to ensure new product introduction is set up for success and can deliver high quality supply 
• Lead site validation activities related to initiating new lines and process improvements. 
• Work with R&D, process and manufacturing engineering departments to develop, conduct and approve product and process validation strategies of products and processes.
• Ensure high quality results on any product transfers

Key additional responsibilities

• Revise, approve, execute IQ, OQ, PQ, TMV, and DOE
• Define sampling plans and approve inspection methods for evaluation and acceptance of components and finished product.
• Provide support in the revision and maintenance of PFMEAs, Quality control plans, process instructions and additional manufacturing documents.
• Evaluate the need for risk mitigation techniques given product classification, potential types of defects, defect frequency, severity, risk for the patient, process capacity, process controls, etc. and monitor effectiveness of these techniques
• Coordinate in process inspection, DHR review, and product release.
• Establish systems to document and maintain process validation and drawing compliance
• Responsible for investigation of product and process issues within manufacturing.
• Prioritize quality engineering projects for completion by the appropriate QA personnel.

Quality Systems Management

• Own manufacturing site QMS in alignment with Corporate QMS 
• Support the ongoing development and implementation of a Corporate Quality System.
• Establish and manage training programs focused on cGMP, QMS, defect awareness, Quality at the Source, and other training programs that promote quality awareness and understanding.
• Monitor development of new or updates to existing regulations and accurately and effectively translates them into workable processes and procedures. 
• Perform periodic non-conformance trend analysis and makes recommendations and reviews associated action plans for NC reduction.
• Promote awareness of regulatory and customer requirements.
• Work across sites to harmonize and/or align processes and best practices.
• Create reports for and manages meetings covering Management Reviews.
• Create bench-marking opportunities to seek best practices with the intention to improve internal processes.
• Manage processes and team associated with manufacturing processes (e.g. incoming inspection, in-process, final inspection, calibration, control of nonconforming products, manufacturing related quality CAPAs/NCEs, deviations, product release, and other Quality Assurance related processes and teams)

Compliance & Analytics

• Ensure compliance to site, corporate, and regulatory requirements as defined by applicable regulatory bodies and agencies.
• Prepare for and lead activities related to third party regulatory (including FDA) audits at manufacturing sites 
• Establish and execute plan for supplier management / development and audits with quality in focus 
• Establish and execute plans for manufacturing audits in collaboration with corporate quality ad ensure the risk management program is state-of-the-art.
• Interface with other departments and partners to ensure implementation of good compliance practices.
• Establish, monitors, and reports metrics and key process indicators and drive actions as needed.
• Develop and manage trending programs, and data analytics with collected data

Education:

• Required Degree: BS Degree - Engineering or related technical degree (Industrial or Mechanical Engineering preferred)
• Masters degree preferred 

Experience:

• Minimum 12-14 years’ experience in Quality Assurance roles in the medical device industry, specifically in a manufacturing / production environment 
• Minimum 7 years of people management experience (preferably in a Technical Manufacturing Environment) with a minimum 2 + years of experience managing mid-level to senior people leaders
• Experience leading supplier quality organizations and working closely with CM/OEMs is highly desired 
• Experience leading manufacturing / operational quality teams in complex electro-mechanical capital and high-volume disposable products manufacturing environment
• Proven track record in effectively leading multi-site, geographically dispersed teams 

Skills/Knowledge:

• Strong understanding of applicable regulations, such as but not limited to, the Medical Device Regulations, IVD Regulation, QSR, ISO 13485, ISO 14971, MDSAP, MDDAP, etc.
• Knowledge of Operational Excellence and Shingo Model desired
• Strong aptitude for troubleshooting mechanical and assay specific events partnering with others through resolution.
• Extremely intuitive with problem solving and resolutions utilizing risk management tools.
• Excellent attention to detail and ability to multi-task.
• Proven people manager and able to work with minimum supervision.
• Ability to inspire, engage, mentor, develop high performing global teams
• Excellent verbal and written communication skills.
• Demonstrated strong change management capability and agility 
• Ability to work effectively in a strongly matrixed team-oriented structure and work collaboratively with cross-functional partners 
• Experience hosting, supporting and/or managing third party audits including FDA, notified bodies etc. 
• Must be able to develop, lead, and motivate a team within a fast-paced manufacturing and design setting.
• High proficiency in Microsoft Suite

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.