Manager, Quality Assurance

Job Description

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .

Responsibilities

CSI believes the quality, safety, and efficacy of our products are of the utmost importance to ensure we deliver impactful solutions that improve healthcare. The Quality Assurance Manager will be responsible for ensuring all products manufactured at the site are manufactured in accordance with appropriate Federal, State & Local regulatory and governing bodies.

Serve as the site head of quality assurance and the management representative at the North Tonawanda, NY manufacturing site.

• Manage, maintain, and continuously improve the quality management system at the site level.
• Provide site quality leadership to the following, but not limited to, quality systems lifecycle maintenance, raw material and final product release, supply chain, automation, manufacturing, validation, product quality complaints, deviations, corrective and preventative actions (CAPAs), and facility engineering.
• Establish, approve, and execute quality procedures to support commercial cGMP production at the site.
• Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high-quality products.
• Lead the preparation and execution of both internal and external audits and serve as the host for regulatory audits/inspections at the site. Job Description
• Maintain Key Performance Indicators and Quality Metrics at the site and present the data to Operations and Senior Quality Leadership on a monthly basis.
• Manage quality assurance personnel and when necessary, recruit, train, and develop quality assurance personnel to meet applicable cGMP compliance requirements and business objectives.
• Manage vendors for any outsourced activities and suppliers for the site and audit the vendors and suppliers as required.
• Represent the site and CooperSurgical at any events, conventions, seminars, trainings, etc. held outside of CooperSurgical facilities.
  
  
  

Qualifications

• Bachelor’s degree in a health or science field required; Advanced degree preferred.
• Minimum of 10 years of experience in pharmaceutical or healthcare industry related experience, 3-5 years of quality assurance management experience, minimum of 5 years of supervisory experience.
• Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations and guidance, and 21 CFR 210, 211, and 820.
• Ability to work with a multidisciplinary team and establish working relationships both internally and externally.
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Experience in hosting regulatory audits/inspections is preferred.
• Ability to read, understand, and write highly technical material.
• Proficient in reading, writing, and communicating in the English language.
  
  
  

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

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.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.