Quality Control Manager

gsknch; Oak Hill (WV); On-site; USD 120,000 - 180,000; Full time

Job summary

Haleon seeks a senior QC leader to direct the site's laboratory operations, ensuring regulatory compliance and robust testing across raw materials, finished products and microbiology. You will drive investigations, QA programs, and CAPA processes while partnering with regulators and internal audit teams.

You will shape strategy, manage budgets and lead a high-performing team to uphold quality and compliance in a fast-paced, global consumer health setting.

Qualifications

• Bachelor's degree in science or relevant field, FDA-regulated industry experience preferred.
• Strong knowledge of cGMPs, FDA expectations, and ICH guidelines.
• Proven ability to lead investigations and manage complex QA activities.

Responsibilities

• Oversee site Quality Control to ensure regulatory compliance and SOP adherence.
• Lead laboratory investigations including OOS and OOT with root-cause analysis.
• Interact with Regulators and internal auditors during inspections.
• Develop and implement CAPAs, metrics, and continuous improvement across the lab.
• Manage budgeting, headcount, and capital spending for the QC department.
• Provide coaching, performance reviews and succession planning for staff.

Skills

Regulatory compliance

Quality management

Analytical skills

Leadership

Project management

CGMP knowledge

Communication

Education

Bachelor's degree in science

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.

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, eff