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Haleon

Global consumer health care products company

Quality Control Manager

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeOak Hill, Durham, NY, USAIn-person

About the Job

Requirements

  • A bachelor's degree in science or a relevant field is required.
  • Eight years of experience in an FDA-regulated industry is required.
  • At least five years of management experience is required.
  • Knowledge of cGMP, FDA, and other regulatory requirements, including ICH Guidelines 8, 9, 10, and 11, is required.
  • Initiative and analytical problem-solving skills are required, including the ability to use and interpret data to drive tactical and strategic decisions.
  • Project management and leadership skills are required.
  • The ability to work under pressure and meet deadlines is required.
  • Flexibility and adaptability are required.
  • Verbal and written communication skills are required.
  • Conflict resolution and interaction management skills are required.

Responsibilities

  • Plan, organize, direct, and control laboratory activities to ensure compliance with corporate policies and governmental regulations.
  • Represent the plant's Quality Control function during FDA, DEA, and internal or corporate inspections, and ensure compliance with site analytical testing requirements.
  • Ensure the Quality Control unit's raw-material, finished-product, and microbiological testing complies with regulatory requirements, company standards, and Site Operating Procedures.
  • Ensure laboratory activities comply with current testing methodologies published by regional pharmacopeia standards, including USP and EP.
  • Establish measurable improvement processes and department metrics to add value for internal and external customers.
  • Lead complex laboratory investigations, including Out of Specification and Out of Trend investigations.
  • Interact with regulators and internal auditors.
  • Support the analytical development program.
  • Drive continuous improvement throughout the laboratory organization in alignment with business and site objectives, and optimize and sustain learning modalities within the analytical team in partnership with Learning and Development.
  • Plan resources and oversee asset utilization.
  • Carry out other assigned quality, product, and compliance activities.
  • Control the departmental budget, including headcount, expenses, and capital, and implement company HR policies.
  • Develop the department's strategy and operational plans.
  • Lead the QC department and support and develop direct reports through coaching or mentoring, appraisals, one-to-ones, training and development, performance management, talent management, and reward and recognition.
  • Establish effective communication within the department, across functions and sites, and between Site Leadership and the department.
  • Ensure proper planning and execution of testing for all samples and materials.
  • Ensure analytical methods are validated and maintained.
  • Ensure analytical equipment is calibrated and qualified before use and remains qualified.
  • Ensure stability samples are tested on time and the stability program is managed; ensure retention samples are appropriately stored and assessed.
  • Ensure the department participates in the site's internal audit program.
  • Participate in FDA and other regulatory inspections and support timely responses to agency observations.
  • Approve GMP-related documentation, including SOPs, Change Controls, Deviations, laboratory investigations, stability reports, validation and qualification documents, and technical reports; approve changes to these documents.

Desired Qualifications

  • Knowledge and application of Quality Management System principles.
  • Project management, organization, and teamwork skills.
  • Interpersonal and communication skills, including negotiation, problem resolution, decision-making, critical aptitude, and interaction with personnel from other areas, disciplines, and external technical advisers, system providers, and consultants.
  • Good oral and written English.
  • Intermediate proficiency with Word, Excel, and PowerPoint.

About the Company

Haleon

Global consumer health care products company

Haleon is a global consumer health company that develops and sells everyday health products under brands such as Sensodyne, Advil, and Centrum. Its products address oral care, pain relief, immunity, and general well-being, working through science-backed formulations people use daily. Haleon differentiates itself by being a focused, standalone consumer health business formed from GSK’s spin-off and built from leading brands through major acquisitions, operating at scale with a portfolio of category leaders and competing with peers like Kenvue and Procter & Gamble. Its goal is to help people take control of their daily health with trusted products, while expanding its global reach and investing in manufacturing capacity and brand development.

Company size
10,001+
Company stage
IPO
Headquarters
Weybridge, United Kingdom
Founded
2022

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