Quality Control Manager

Haleon • Town of Durham, NY

4d • $130,355 - $177,757

About The Position

The Quality Control Manager plans, organizes, directs, and controls laboratory activities to ensure compliance with corporate policies and governmental regulations. The role serves as the plant’s official QC representative during FDA, DEA, and internal or corporate inspections, and assures compliance with site analytical testing requirements.

The manager leads the QC department’s raw materials, finished product, and microbiological testing, ensuring regulatory compliance and adherence to company standards, SOPs, and current regional pharmacopeia methodologies. The role develops the department’s strategy and operational plans, leads improvement and capability initiatives, and oversees laboratory investigations, analytical development, testing, method validation, equipment qualification, stability testing, and retention samples.

The position provides leadership, coaching, and development for department employees; manages department resources, asset utilization, budgets, headcount, expenses, and capital; and establishes effective communication within the department, across functions and sites, and with Site Leadership. The manager also participates in internal audits and regulatory inspections and approves GMP-related documentation and associated changes.

Requirements

• Bachelor’s degree in science or a relevant field.
• Eight years of experience in an FDA-regulated industry.
• At least five years of management experience.
• Knowledge of cGMP, FDA, and other regulatory requirements, including ICH Guidelines 8, 9, 10, and 11.
• Initiative and analytical problem-solving skills, including the ability to use and interpret data to support tactical and strategic decision-making.
• Project management and leadership skills.
• Ability to work effectively under high pressure and deadlines.
• Flexibility, adaptability, teamwork, and leadership that fosters teamwork and promotes company values, behaviors, and strategies.
• Excellent verbal and written communication skills.
• Conflict resolution and interaction management skills.

Nice To Haves

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

Responsibilities

• Direct laboratory activities to assure compliance with corporate policies, governmental regulations, company standards, site operating procedures, and regulatory agency requirements.
• Represent the plant’s Quality Control function during FDA, DEA, internal, and corporate inspections; interact with regulators and internal auditors.
• Ensure compliance with current analytical testing methodologies published by regional pharmacopeia standards, including USP and EP.
• Establish measurable improvement processes and metrics across the department.
• Lead complex laboratory investigations, including Out of Specification (OOS) and Out of Trend (OOT) investigations.
• Lead the analytical development program.
• Foster continuous improvement and capability development throughout the laboratory organization, including learning and development initiatives.
• Plan resources and oversee asset utilization.
• Manage departmental budget controls, including headcount, expenses, and capital, and comply with HR company policy.
• Develop the department’s strategy and clear operational plans.
• Lead, support, and develop department employees through coaching, mentoring, appraisals, one-to-ones, training and development, performance management, talent management, and reward and recognition.
• Establish effective two-way 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 adequately validated and maintained.
• Ensure analytical equipment is calibrated and qualified before use and remains in a qualified state.
• Ensure stability samples are tested on time and the stability program is appropriately managed; ensure retention samples are kept and assessed.
• Ensure the department participates in the site’s internal audit program.
• Support timely responses to regulatory agencies for inspection observations.
• Approve GMP-related documentation, including SOPs, Change Controls, Deviations, laboratory investigations, stability reports, validation and qualification documents, and technical reports, including associated changes.
• Carry out other assigned quality, product, and compliance activities.

Benefits

• Competitive pay.
• Comprehensive benefits program.
• Generous 401(k) plan.
• Tuition reimbursement.
• Time-off programs.
• Six months of paid parental leave.
• Benefits eligibility beginning on day one.
• Healthcare programs, with the company paying for the majority of medical coverage for the employee and family.
• Opportunity for a discretionary bonus based on achievement of key business performance.
• Other incentive and recognition programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager