Quality Control Manager

12293 Haleon US Holdings LLC; Oak Hill (TN); On-site; USD 130,000 - 178,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Paid parental leave

Job summary

Haleon, a leading consumer health company, seeks a Laboratory Quality Control leader to plan, organize, direct and control all QC activities, ensuring compliance with cGMP, FDA and regulatory standards, and serving as the plant’s official QC representative during inspections.

You will lead investigations, manage resources and budgets, drive continuous improvement, and mentor the QC team while partnering with regulators, internal auditors and site leadership to deliver high-quality products.

Qualifications

• Bachelor’s degree in science or relevant field; 8 years of experience in an FDA regulated industry.
• Minimum of 5 years’ management experience.
• Knowledge of cGMP’s/FDA and regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
• Demonstrate initiative and analytical problem-solving skills; ability to drive tactical and strategic decisions.
• Project management and leadership skills; ability to work under high pressure and deadlines.

Responsibilities

• Ensure the site Quality Control unit (raw materials testing, finished product testing, and microbiological testing) operates in compliance with regulatory agencies’ requirements, company standards, and Site Operating Procedures (SOPs).
• Ensure laboratory activities comply with current testing methodologies published by regionally accepted Pharmacopeia standards (USP/EP and others).
• Establish stretching, measurable improvement processes and metrics across the department.
• Lead complex laboratory investigations (OOS and OOT).
• Interact with Regulators and internal auditors.
• Analytical development program.
• CI & Capability—drive CI throughout the lab in harmony with objectives; partner with L&D and learning modalities.
• Resource planning and oversight of asset utilization.
• Provide responsibility for other quality, product, and/or compliance activities.
• Oversee department budget controls and HR policy.
• Develop strategy and operational plans for the department.
• Provide leadership to the QC department with reporting support.
• Act as a coach/mentor with appraisals, training and performance management.
• Communicate to ensure smooth cross-functional communications within and across sites.
• Ensure two-way communications between Site Leadership and the department.
• Plan and execute testing of all samples and materials.
• Ensure analytical methods are validated and maintained; calibrate and qualify equipment.
• Manage stability and retention sample programs; participate in internal audits.
• Support FDA and other regulatory inspections; respond to observations.
• Approve GMP documentation and changes (SOPs, Changes, Deviations, Investigations, Stability reports, Validation/Qualification).

Job description

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

About the role

Plans, organizes, directs and controls the entire Laboratory activities to assure full compliance with corporate policies and governmental regulations. Acts as an official Quality Control (QC) representative of the plant during FDA, DEA and internal/Corporate Inspections. Assures plant compliance with analytical testing requirements for the site.

Role Responsibilities

• Ensure the site Quality Control unit (raw materials testing, finished product testing, and microbiological testing) operates in compliance with regulatory agencies’ requirements, company standards, and Site Operating Procedures (SOPs).
• Ensure that laboratory activities comply with the most current testing methodologies published by regional Pharmacopeia standards (USP/EP and other)
• Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
• Lead complex laboratory investigations (LIs) including Out of Specification (OOS) and Out of Trend (OOT).
• Interact with Regulators and internal auditors.
• Analytical development program.
• CI & Capability (foster and drive CI throughout the lab organization in harmony with business & site objectives; in partnership with learning and development, optimizing and sustaining all the learning modalities within the analytical team.)
• Responsible for resource planning and oversight of asset utilization.
• Provide responsibility for other quality, product, and/or compliance activities as assigned.
• Is responsible for departmental budget controls (headcounts, expenses & capital) and HR company policy.
• Develops the strategy and clear operational plans for the department.
• Provides leadership to the QC department with responsibility for supporting and developing reports.
• Acts as a coach or mentor using appraisals, 1:1’s, training and development, performance management, talent management and reward and recognition.
• Communicates effectively and establishes processes to ensure smooth communication within the department, across functions and across sites.
• Ensures two-way communications between Site Leadership and the department.
• Ensure proper planning and execution of testing of all samples and materials.
• Ensure that analytical methods are adequately validated and maintained.
• Ensure that analytical equipment is adequately calibrated and qualified prior to use and continuously kept in a qualified state.
• Ensure that stability samples are tested on time and the stability program is adequately managed.
• Ensure that retention samples are adequately kept and assessed.
• Ensures department participate in site’s internal audit program.
• Actively participate in FDA and other regulatory inspections for the site; support the issuance of a timely response to the Agency for any observations.
• Approves GMP related documentation such as SOPs, Change Controls, Deviations, Lab investigations, Stability reports, Validation/Qualification documents and Technical Reports.
• Approves any changes associated with these documents.

Why you?

Basic Qualifications: Bachelor’s degree in science or relevant field 8 years of experience in an FDA regulated industry Minimum of 5 years’ management experience Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11. Demonstrate initiative and analytical problem-solving skills – ability to use and interpret data to drive decision making at both tactical and strategic level. Requires project management and leadership skills. Ability to work well under high pressure and deadlines Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies. Excellent verbal and written communication skills required. Conflict resolution and interaction management skills required.

Preferred Qualifications

• Knowledge and application of the principles of Quality Management Systems (QMS)
• Project management, organization, and teamwork skills.
• Interpersonal and communication skills (teamwork, effective negotiation, resolution of problems, decision making, critical aptitude, ability to interact with personnel from other areas, other disciplines and with external personnel (technical advisers, system providers, consultants for systems, among others).
• Language: English, good oral and written level.
• Computer Tools: Word, Excel, Power Point intermediate level.

Teh salary range for this position is $130,355 to 177,757 plus a 12% Performance Bonus.

Benefits Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

2026-11-30

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong. During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to [e-mail]. Please include the following in your email: Use subject line: ‘Haleon Careers: Job Accommodation Request’ Your Name and contact information Requisition ID and Job Title you are interested in Location of Requisition (city/state or province/country) Description of specific accommodation you are requesting Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.