Manager, Quality Validation

Kenvue Brands LLC • Fort Washington, PA

98d • $124,100 - $175,200

About The Position

The Manager, QA Validation is responsible for managing daily operations of the QA validation department, designing and developing validation policies and procedures, and ensuring continuous improvement in line with regulatory requirements. The role reports to the Site Quality Director and is located in Fort Washington, Pennsylvania, fully onsite.

Requirements

• Bachelors Degree in Engineering, Chemistry, Microbiology or a related field.
• Minimum 8-10 years of experience in quality validation, preferably within the drug industry.
• Strong leadership skills with the ability to mentor and motivate team members.
• In-depth knowledge of regulatory requirements and quality standards, especially in the areas of equipment commissioning and qualification, cleaning validation, computer system validation, and process performance qualification.
• Strong organization skills and ability to manage multiple competing priorities.

Nice To Haves

• Proven track record of leading key enabling functions.
• Exceptional analytical skills to interpret complex business data and make informed decisions.
• Ability to influence decision-making at plant leadership level.
• Effective leadership in navigating ambiguity, conflict, and complexity.
• Demonstrated alignment with Leadership Imperatives through behaviors and actions.
• Excellent communication skills, both verbal and written.

Responsibilities

• Lead a team of QA professionals to ensure compliance with industry standards for Commissioning & Qualification (C&Q), cleaning validation, manufacturing process qualification, packaging line trials (PLT) process performance validation (PPQ), and computer system validation (CSV).
• Collaborate with cross-functional teams to achieve site and company objectives.
• Lead cross-functional teams to drive continuous improvement in validation processes and strategies, as necessary.
• Stay updated on industry trends and regulatory requirements to provide expert guidance on validation activities.
• Collaborate with senior management to address critical business issues and identify growth opportunities.
• Ensure strict adherence to Health, Safety, and Environmental guidelines in all validation practices.
• Represent FWP QA at VRC and TRF.
• Provide quality support and oversight to the criticality assessment process.
• Support New Product Introduction (NPI), Technical Transfer (TT) and continuous improvement projects.
• Support in house deviation processes, providing insights and validation input.
• Interact with Regulatory Health Authority representatives during inspections as an SME.
• Support responses to Regulatory Health Authorities.
• Responsible for accurate preparation, review and approval of protocols and reports.
• Responsible for ensuring adherence to protocol sampling plans.
• Responsible for collecting and providing required APR/PQR quality attribute data and analysis of the data.
• QA Validation SME with responsibility for understanding the critical aspect of products, components and labeling requirements.
• Coordinate with regional and global teams to standardize the validation process and communicate trends in audit findings and actions.

Benefits

• Annual base salary for new hires in this position ranges: $124,100.00 - $175,200.00.
• Competitive Benefit Package including Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities.
• Kenvuer Impact Networks.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree