About the rolePlans, 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.
BenefitsHaleon 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 Date2026-11-30
