Vice President, Global Quality

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Company: CooperSurgical
Location: Trumbull, CT

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Position Summary

The VP, Global Quality will lead the Quality team, and work cross-functionally to maintain standards for compliance across all CooperSurgical sites to ensure product quality and patient safety. This position will have a high degree of visibility and impact across the organization. The VP, Global Quality will need the skills to work effectively in a dynamic, cross-functional, international organization. The VP, Global Quality will bring a strong strategic mindset and a proven track record of leading Quality activities for all GxP functions including Quality Systems, oversight of Quality Operations for laboratories (GLP), suppliers, and/or contract manufacturing and testing (GMP), Quality IT Validation, and Quality oversight of postmarket surveillance activities for both Medical Devices and pharmaceutical products.


Essential Functions

  • Responsible for maintaining a corporate Quality Management System and Quality team that promotes customer satisfaction and that positively impacts the financial performance of the company.
  • Provide leadership, guidance and context to the GXP Quality organization comprised of quality systems, research quality, and quality operations, and evolve the vision and strategy for Quality as the company grows and expands internationally.
  • Spearhead the evolution of the quality system and development of the quality team with a focus on Cooper’s mission of a world with healthy women, babies and families by championing an organizational culture upon a foundation of safety, quality, sustainability and compliance.
  • Formulate, establish and maintain policies and procedures and accompanying systems across all CooperSurgical sites and ensure compliance in adherence to national and international regulatory requirements.
  • Champion a continuous improvement mindset and execution across the organization. Continuously improve the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements.
  • Engage cross-functional stakeholders to align on and achieve Quality related objectives
  • Execute independent oversight of product quality decisions and GXP activities
  • Represent Quality initiatives and decisions across a broad range of departments and levels of management including the Leadership Team.
  • Ensure timely and effective communication and escalation to raise quality issues to the appropriate levels of management. Apprise senior management of critical issues and plans for remediation or resolution.
  • Act as primary point of contact for regulators during site inspections by FDA, ISO and any other inspections pertaining to GXP requirements.
  • Partner cross functionally on all levels to select appropriate suppliers, contract organizations and/or testing houses. Engage third party organizations to ensure effective and clear agreements are in place to execute and monitor Quality accountabilities, including but not limited to inspection management.
  • Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GXP activities.
  • Performs other duties or assignments as required by management.

Qualifications

  • Thrives in a fast-paced, innovative environment.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and influencing skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
  • Demonstrated ability to translate strategy into action; excellent critical thinking, analytical skills and an ability to communicate complex issues in a simple way. Able to orchestrate plans to resolve issues and mitigate risks.
  • Bachelor’s degree preferably in a scientific or technical discipline; advance degree a plus
  • Minimum 15 years experience in the medical device industry with a minimum 10 years in a quality management role.
  • Proven knowledge and experience of relevant regulations such as ISO 13485, and 21 CFR Parts 210, 211, 314 and 820, especially pertaining to product development, manufacturing, supplier management, quality control and postmarket surveillance.
  • Proven leadership ability to align, motivate and empower teams
  • Strong written and verbal communication and presentation skills.
  • Expertise in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company
  • Strong team player that has a customer service approach and solution oriented.
  • Champion of continuous improvement with change management experience, including
  • successful leadership of organizational transformation within relevant Quality functions.
  • Demonstrated success in leading inspections by FDA and other regulatory agencies.
  • Success with anticipation and prevention of long-range problems. Strategic effectiveness in long-term problem solving.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran


To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.