Quality Control Manager
Haleon · Oak Hill, NY · 3 wk ago
On-siteQuality AssuranceFull-time
Haleon is a purpose‑driven, world‑class consumer health company with a portfolio that includes Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin® and Centrum®. The company is focused on delivering better everyday health with humanity through its “Win as One” strategy.
About the Role
Plans, organizes, directs and controls the entire laboratory activities to assure full compliance with corporate policies and governmental regulations. Acts as the official Quality Control (QC) representative of the plant during FDA, DEA and internal/Corporate inspections and ensures compliance with analytical testing requirements for the site.
Responsibilities
- Ensure the site QC unit (raw materials, finished product, and microbiological testing) operates in compliance with regulatory agencies, company standards, and Site Operating Procedures (SOPs).
- Maintain laboratory activities in line with current testing methodologies published by regional Pharmacopeia standards (USP/EP and others).
- Establish measurable improvement processes and metrics across the department to add value to internal and external customers.
- Lead complex laboratory investigations, including Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) cases.
- Interact with regulators and internal auditors; support analytical development programs.
- Foster and drive continuous improvement throughout the lab organization in partnership with learning and development.
- Plan resources and oversee asset utilization.
- Manage departmental budget controls (headcount, expenses, capital) and adhere to HR policies.
- Develop strategy and clear operational plans for the department.
- Provide leadership, coaching, and mentorship through appraisals, 1:1s, training, performance management, talent management, and recognition.
- Facilitate effective two‑way communication between site leadership and the QC department.
- Plan and execute testing of all samples and materials; ensure analytical methods are validated and maintained.
- Ensure analytical equipment is calibrated, qualified, and kept in a qualified state.
- Manage stability testing program and retention sample handling.
- Participate in the site’s internal audit program.
- Actively participate in FDA and other regulatory inspections; support timely response to observations.
- Approve GMP‑related documentation (SOPs, Change Controls, Deviations, Lab investigations, Stability reports, Validation/Qualification documents, Technical Reports) and any associated changes.
Requirements
- Basic Qualifications:
- Bachelor’s degree in science or a relevant field.
- 8 + years of experience in an FDA‑regulated industry.
- Minimum of 5 years’ management experience.
- Knowledge of cGMP, FDA, and other regulatory requirements (ICH Guidelines 8‑11).
- Initiative and analytical problem‑solving skills; ability to interpret data for tactical and strategic decisions.
- Project management and leadership skills.
- Ability to work under high pressure and tight deadlines.
- Flexibility, adaptability, strong teamwork, and alignment with company values.
- Excellent verbal and written communication skills.
- Conflict resolution and interaction management skills.
- Preferred Qualifications:
- Knowledge and application of Quality Management Systems (QMS) principles.
- Advanced project management, organization, and teamwork abilities.
- Strong interpersonal and communication skills, including negotiation, problem resolution, decision making, and cross‑functional collaboration.
- Fluent English (oral and written).
- Intermediate proficiency with Microsoft Word, Excel, and PowerPoint.
Pay
Salary range: $130,355 – $177,757 plus a 12 % performance bonus.
Benefits
- Robust total‑reward package with competitive pay.
- Comprehensive benefits program, including a generous 401(k) plan.
- Tuition reimbursement.
- Six months of paid parental leave.
- On‑day‑one eligibility for healthcare coverage, with the company covering the majority of medical costs for employees and families.
- Discretionary bonus based on key business performance.
- Additional incentive and recognition programs.