Background & Purpose of the Job
The Quality Compliance Lead is responsible for ensuring site compliance with FDA regulations, cGMP requirements, corporate standards, and Quality Management System expectations. The role drives inspection readiness, CAPA management, regulatory remediation programs, quality system effectiveness, and cross-functional compliance initiatives while providing leadership with clear visibility of compliance risks and performance. S/he works as a core member of the Quality team to manage site compliance to achieve World Class Quality performance as measured by our core Key Performance Indicators in the DEO Center of Excellence.
Who You Are & What You’ll Do
• Lead the site’s regulatory compliance program and oversee execution of FDA, BRC, Corporate and Internal Quality Commitments to complete and maintain internal and external audits and certifications.
• Manage and track all corrective and preventive actions (CAPAs), ensuring actions are completed on time and sustained through effectiveness verification.
• Coordinate inspection readiness activities, mock inspections, regulatory audits, and responses to regulatory observations.
• Provide independent oversight of deviation investigations, root cause analyses, product impact assessments, and CAPA implementation.
• Ensure consumer complaint investigations are completed accurately, thoroughly, and within established timelines.
• Oversee data integrity programs, including audit trail review, electronic records management, backup controls, and compliance with computerized system requirements.
• Monitor compliance of maintenance, calibration, preventive maintenance, and work order systems affecting GMP equipment and product quality.
• Govern equipment integrity programs, including risk assessments, inspection programs, interim controls, and long-term remediation projects.
• Lead compliance oversight of validation programs, including cleaning validation, process validation, equipment qualification, and revalidation activities.
• Ensure equipment history, maintenance records, and quality documentation are complete, accurate, and audit ready.
• Oversee annual reserve sample inspection programs and ensure compliance with applicable FDA requirements and site procedures
• Develop, monitor, and report compliance metrics, trends, risks, and regulatory commitments to Site Leadership and Quality Management Review.
• Partner with Quality, Operations, Engineering, Maintenance, R&D, and Supply Chain teams to drive continuous improvement and strengthen quality systems.
• Ensure new and revised procedures are effectively implemented through training, auditing, and ongoing compliance verification.
• Escalate compliance risks, overdue actions, recurring quality issues, and regulatory concerns to senior management when appropriate.
• Management of yearly regulatory testing requirements.
• Manage the site’s change management process.
• Participate in the Quality Pillar as a core team member and help in defining relevant KPIs, building scorecards & reports for Quality KPIs, analyzing data and drawing insights to drive Quality improvement using advanced statistical tools (SPC and Capability analysis).
• Ensure good manufacturing practices are always in place; set example and champion Quality initiatives
• Maintain knowledge of current industry standards and best practices by actively engaging in relevant learning, networking, and professional development opportunities..
• You’re a born leader: You are self-directed, identifying problems and proactively solving using proven problem solving methods
• You love to win, and have fun doing it: We have fun while ensuring the customer expectations are met each and every time.
• You’re a story teller: We look at trends to determine best next steps based on the data story.
• You’re a teacher: You thrive on educating and teaching the plant in the ways of a great quality system.
What You’ll Need To Succeed
Professional Skills
ESSENTIAL:
• Bachelor’s degree in technical discipline or general sciences
PREFERRED:
• Biology, Chemistry, Engineering, Food Science or Microbiology degree
Experience Required
ESSENTIAL:
• 3 years Substantial experience in Quality Assurance, regulatory compliance, manufacturing compliance, validation, engineering quality, or another relevant cGMP function.
• Working knowledge of FDA cGMP requirements applicable to OTC or Drug manufacturing.
• Working knowledge of Data Integrity, Validations and CAPA.
PREFERRED / DESIRABLE:
• Experience in an FDA-regulated OTC drug, pharmaceutical, combination-product, or similarly regulated manufacturing environment.
• Strong Analytic & technical thought process
Excellent oral, written communication and effective interpersonal skills. Strong written communication, meeting facilitation, project coordination, and escalation skills. The ability to manage confidential regulatory and sensitive information. Attention to detail is a must.
What We Can Offer You
Culture for Growth | Top Notch Employee Health & Well Being Benefits | Every Voice Matters | Global Reach | Life at Unilever | Careers with Purpose | World Class Career Development Programs | Check Out Our Space | Focus On Sustainability
Internal Postings Only
By applying for this vacancy, you are confirming that you have made your Line Manager aware of your application and that you are at a point in your career with Unilever where it is appropriate for you to be applying for other positions.
Internal/External Postings:
Please note: as part of the job application, you will be asked to complete pre-screening questions. Completion of the pre-screening questions are mandatory in order to be considered. Please allow yourself plenty of time to complete both the application and pre-screening questions. If the pre-screening questions are partially answered or not at all, it will adversely affect the progress of your application. Please be aware that you will have to complete the pre-screening questions at once as you will be unable to return to it later.
Internal/External Postings:
Unilever is an organization committed to diversity and inclusion to drive our business results and create a better future every day for our diverse employees, global consumers, partners, and communities. We believe a diverse workforce allows us to match our growth ambitions and drive inclusion across the business.
Equal Opportunity/Affirmative Action Employer Minorities/Females/Protected Veterans/Persons with Disabilities
Applicants and employees are protected from discrimination under Federal law. For more information, please see EEO is the Law.
Canada EEO
Unilever is an equal opportunity employer. It prohibits discrimination based on age, ethnicity, disability, national origin, race, religion, gender, family status, sexual orientation, and any other legally protected class in accordance with applicable federal, provincial and local laws.
Background Checks: External Only
Employment is subject to verification of pre-employment drug-screening results, Motor Vehicle Records check and background investigation.
Employment is subject to verification of pre-employment drug-screening results, Motor Vehicle Records check, Credit check, and background investigation.
Employment may subject to verification of Motor Vehicle Records check
External Only:
To receive communication about your application, please add careers@unilever.com to your safe senders list, and ensure your mobile phone number is correctly entered in your application.
Pay: The pay range for this position is $88,600 to $133,000. Unilever takes into consideration a wide range of factors that are utilized in making compensation decisions including, but not limited to, skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs.
Bonus: This position is bonus eligible.
Benefits: Unilever employees are eligible to participate in our benefits plan. Should the employee choose to participate, they can choose from a range of benefits to include, but is not limited to, health insurance (including prescription drug, dental, and vision coverage), retirement savings benefits, life insurance and disability benefits, parental leave, sick leave, paid vacation and holidays, as well as access to numerous voluntary benefits. Any coverages for health insurance and retirement benefits will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents.
------------------------------------
At Unilever, inclusion is at the heart of everything we do. We welcome applicants from all walks of life and are committed to creating an environment where everyone can thrive/succeed. All applicants will receive fair and respectful consideration, and we actively support the growth and development of every employee.
Unilever is an Equal Opportunity Employer/Protected Veterans/Persons with Disabilities.
For more information on your federal rights, please see Know Your Rights: Workplace Discrimination is Illegal
Employment is subject to verification of pre-screening tests, which may include drug screening, background check, credit check and DMV check.
If you are an individual with a disability in need of assistance at any time during our recruitment process, please contact us at NA.Accommodations@unilever.com. Please note: This email is reserved for individuals with disabilities in need of assistance and is not a means of inquiry about positions or application statuses. The Protected Veterans or Individuals with Disabilities AAP narratives are available for inspection by any employee or applicant for employment Monday through Friday during normal business hours at establishment.