This position reports to QA Quality Systems Manager and is based at Lititz, PA.
Who we are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's and BAND-AID® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here.
Role reports to: QA Quality Systems Manager
Location: Lititz
Travel %: 10
What you will do
The Supervisor Quality Systems is responsible for providing Quality oversight of automation and electronic principles, practices and documentation. Will maintain ownership of electronic Quality systems and processes dedicated to the Quality Assurance and Quality Control departments. Makes assessments regarding compliance of modifications to, or implementation of site electronic systems.
Key Responsibilities
• Review and approve Annual Product and Computer System Review protocols and processes.
• Supervise Master data and lab system Computer System Validation.
• Review and approve system development lifecycle validation documentation.
• Perform temperature monitoring and remediation for the site.
• Document investigations and rationales which are technically accurate and regulatory compliance focused.
• Documentation of investigations, CAPAs, technical justifications, quality reports, metrics, trend analysis and audit responses.
• Leads effective communication between multi-functional teams during their interim assignment and provides practical solutions based on objective analysis and use of limited data as applicable.
• Responsible for leading a team and managing day to day schedules, as applicable
• Review of plant calibration and maintenance change requests, impact assessments and out of tolerance reports.
What we are looking for
Required Qualifications
Minimum of a Bachelor's Degree (preferably in engineering or science)
A minimum of six (6) to eight (8) years of GMP experience (or five (5) years of experience in a QA role, with plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production
Desired Qualifications
Detailed working knowledge of cGMP requirements and current FDA enforcement issues across multiple regulatory classes of consumer products.
Computer system administration and validation experience.
ASQ certification(s)
What's in it for you
• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
• This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
