Manager, Quality Compliance - Colgate-Palmolive
Morristown, TN
About the Job
No Relocation Assistance Offered
# 163018 - Morristown, Tennessee, United States
Who We Are
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom’s of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Pet Nutrition.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children’s oral health.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team!
Manager, Quality Compliance
The Manager, Quality Compliance directs conformance to the GMP/Quality standards and establishes a culture to enable the site to deliver consistent, safe, and effective products. Positive Release of Finished product is at the core of this position’s daily responsibility. A key role is to maintain a comprehensive site documentation system, author and maintain the site Validation Master Plan, and ensure site-wide compliance to 21CFR Parts 11, 210, 211, and 820.
Responsibilities Include:
+ Coaches and mentors site personnel in regards to Compliance issues.
+ Lead/participate in consumer/customer satisfaction improvement initiatives.
+ Support the development, implementation, and monitoring of the manufacturing site Quality Plan to ensure compliance with both GMP’s and CP Global Quality Standards.
+ Responsible for daily documentation authorizing product release and the execution of release procedure.
+ Interpret and communicate regulatory policies and requirements to CP personnel (local resident expert and leader for compliance and related GMP concerns).
+ Management of plant Documentation system (This includes all documents vital to an FDA inspection- SOP’s, Management of Change, Notices of Deviation, Batch Records, Nonconformances, and Validations)
+ Supervise Consumer Complaint trends and history. Ensures that all returned samples and adverse event complaints are fully investigated and documented.
+ Manage the Tennessee site Annual Product Review and Mock Recovery and Recall and provide necessary compliance documentation and corrective action strategies for continuous improvement
+ Ensure that the designs, specifications, implementation, and maintenance of an cGMP system follows current regulations and CP standards
+ Supervision of site’s Management of Change (MOC), CAPA and internal audit programs.
+ Supervision and management of FDA Drug Listings and international drug registrations.
+ Leads site GMP walkthroughs
+ Release finished goods to trade
+ Lead quality council meeting to review quality critical metrics
Required Qualifications
+ Bachelor’s Degree in Chemistry, Microbiology, Biochemistry, Engineering, or a related field
+ Minimum 5 years experience in a manufacturing plant operating in a Food or Drug / GMP environment
+ Extensive knowledge of site wide documentation system, Product Release, and Batch record review
+ Must be familiar with and able to implement GMP compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation
+ Knowledge of Change Control Systems
+ Leadership skills to move to higher management position
+ Knowledge of FDA regulation
+ First-hand experience managing or supporting regulatory inspections
+ Experience with SAP QM
Preferred Qualifications
+ Supervisory experience.
+ Building and supporting strategic relationships and common programs with Product Development, Regulatory Affairs, Supply Chain Management, EOHS, and Global Materials, Logistics & Sourcing Departments, as well as material/component suppliers is also an expectation of this position.
+ 2 years of experience preparing documentation for Product Registration in country of sale, managing Consumer Complaints and completing Product Release documentation and final approval
+ Experience in hosting/leading FDA inspection is highly desired
+ Experience with utilization of statistical tools (e.g. MiniTab)
Compensation and Benefits
Salary Range $102,400.00 - $144,000.00 USD
Pay is based on multiple non-discriminatory, individualized factors including but not limited to experience, job-related knowledge and education, skills and office/market location. In addition to base salary, salaried employees are eligible for annual discretionary bonuses, profit-sharing and, for Executive-level (salary grade 16 and above) roles only, long-term incentives in the form of Restricted Stock Units and/or Stock Options.
Subject to the terms and conditions of the applicable benefits plans then in effect, all salaried employees are also eligible for a competitive benefits package which includes:
+ Insurance: Employees (and their eligible dependents) are eligible to participate in Company-sponsored Medical, Dental, Vision, Basic Life Insurance, Accidental Death & Dismemberment and Disability insurance plans.
+ Retirement Plans: Employees are eligible to enroll in Colgate's 401(k) plan, which provides for company matching contributions subject to eligibility requirements
+ Vacation/PTO: Employees receive a minimum of 15 days of vacation/PTO leave annually
+ Paid Holidays: Employees receive a minimum of 13 paid/floating holidays annually
+ Paid Sick Leave: Based on location and consistent with applicable state and local law, employees receive a minimum of 40 hours of paid sick leave on January 1st of each year
+ Paid Parental Leave: Eligible employees may take up to eight weeks of paid parental leave and 12 weeks of unpaid leave (varies for employees with fewer than 12 months of service and is subject to hours worked requirements)
Our Commitment to Sustainability
With the Colgate brand in more homes than any other, we are presented with great opportunities and new challenges as we work to integrate sustainability into all aspects of our business and create positive social impact. We are determined to position ourselves for further growth as we act on our 2025 Sustainability & Social Impact Strategy.
Our Commitment to Diversity, Equity & Inclusion
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject "Accommodation Request" should you require accommodation.
For additional Colgate terms and conditions, please click here (https://www.colgatepalmolive.com/content/dam/cp-sites/corporate/corporate/en_us/corp/locale-assets/pdf/colgate-terms-and-conditions-2023.pdf) .
#LI-On-site
# 163018 - Morristown, Tennessee, United States
Who We Are
Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom’s of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Pet Nutrition.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children’s oral health.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team!
Manager, Quality Compliance
The Manager, Quality Compliance directs conformance to the GMP/Quality standards and establishes a culture to enable the site to deliver consistent, safe, and effective products. Positive Release of Finished product is at the core of this position’s daily responsibility. A key role is to maintain a comprehensive site documentation system, author and maintain the site Validation Master Plan, and ensure site-wide compliance to 21CFR Parts 11, 210, 211, and 820.
Responsibilities Include:
+ Coaches and mentors site personnel in regards to Compliance issues.
+ Lead/participate in consumer/customer satisfaction improvement initiatives.
+ Support the development, implementation, and monitoring of the manufacturing site Quality Plan to ensure compliance with both GMP’s and CP Global Quality Standards.
+ Responsible for daily documentation authorizing product release and the execution of release procedure.
+ Interpret and communicate regulatory policies and requirements to CP personnel (local resident expert and leader for compliance and related GMP concerns).
+ Management of plant Documentation system (This includes all documents vital to an FDA inspection- SOP’s, Management of Change, Notices of Deviation, Batch Records, Nonconformances, and Validations)
+ Supervise Consumer Complaint trends and history. Ensures that all returned samples and adverse event complaints are fully investigated and documented.
+ Manage the Tennessee site Annual Product Review and Mock Recovery and Recall and provide necessary compliance documentation and corrective action strategies for continuous improvement
+ Ensure that the designs, specifications, implementation, and maintenance of an cGMP system follows current regulations and CP standards
+ Supervision of site’s Management of Change (MOC), CAPA and internal audit programs.
+ Supervision and management of FDA Drug Listings and international drug registrations.
+ Leads site GMP walkthroughs
+ Release finished goods to trade
+ Lead quality council meeting to review quality critical metrics
Required Qualifications
+ Bachelor’s Degree in Chemistry, Microbiology, Biochemistry, Engineering, or a related field
+ Minimum 5 years experience in a manufacturing plant operating in a Food or Drug / GMP environment
+ Extensive knowledge of site wide documentation system, Product Release, and Batch record review
+ Must be familiar with and able to implement GMP compliant Failure Investigations, Corrective and Preventive Actions, and Notices of Deviation
+ Knowledge of Change Control Systems
+ Leadership skills to move to higher management position
+ Knowledge of FDA regulation
+ First-hand experience managing or supporting regulatory inspections
+ Experience with SAP QM
Preferred Qualifications
+ Supervisory experience.
+ Building and supporting strategic relationships and common programs with Product Development, Regulatory Affairs, Supply Chain Management, EOHS, and Global Materials, Logistics & Sourcing Departments, as well as material/component suppliers is also an expectation of this position.
+ 2 years of experience preparing documentation for Product Registration in country of sale, managing Consumer Complaints and completing Product Release documentation and final approval
+ Experience in hosting/leading FDA inspection is highly desired
+ Experience with utilization of statistical tools (e.g. MiniTab)
Compensation and Benefits
Salary Range $102,400.00 - $144,000.00 USD
Pay is based on multiple non-discriminatory, individualized factors including but not limited to experience, job-related knowledge and education, skills and office/market location. In addition to base salary, salaried employees are eligible for annual discretionary bonuses, profit-sharing and, for Executive-level (salary grade 16 and above) roles only, long-term incentives in the form of Restricted Stock Units and/or Stock Options.
Subject to the terms and conditions of the applicable benefits plans then in effect, all salaried employees are also eligible for a competitive benefits package which includes:
+ Insurance: Employees (and their eligible dependents) are eligible to participate in Company-sponsored Medical, Dental, Vision, Basic Life Insurance, Accidental Death & Dismemberment and Disability insurance plans.
+ Retirement Plans: Employees are eligible to enroll in Colgate's 401(k) plan, which provides for company matching contributions subject to eligibility requirements
+ Vacation/PTO: Employees receive a minimum of 15 days of vacation/PTO leave annually
+ Paid Holidays: Employees receive a minimum of 13 paid/floating holidays annually
+ Paid Sick Leave: Based on location and consistent with applicable state and local law, employees receive a minimum of 40 hours of paid sick leave on January 1st of each year
+ Paid Parental Leave: Eligible employees may take up to eight weeks of paid parental leave and 12 weeks of unpaid leave (varies for employees with fewer than 12 months of service and is subject to hours worked requirements)
Our Commitment to Sustainability
With the Colgate brand in more homes than any other, we are presented with great opportunities and new challenges as we work to integrate sustainability into all aspects of our business and create positive social impact. We are determined to position ourselves for further growth as we act on our 2025 Sustainability & Social Impact Strategy.
Our Commitment to Diversity, Equity & Inclusion
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please contact Application_Accommodation@colpal.com with the subject "Accommodation Request" should you require accommodation.
For additional Colgate terms and conditions, please click here (https://www.colgatepalmolive.com/content/dam/cp-sites/corporate/corporate/en_us/corp/locale-assets/pdf/colgate-terms-and-conditions-2023.pdf) .
#LI-On-site
Source : Colgate-Palmolive