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About the Role

Plans, organizes, directs, and controls all laboratory activities to ensure compliance with corporate policies and governmental regulations. Serves as the official Quality Control (QC) representative during regulatory inspections and ensures plant compliance with analytical testing requirements.

Responsibilities

Ensure the site Quality Control unit operates in compliance with regulatory agencies’ requirements, company standards, and Site Operating Procedures (SOPs).
Ensure laboratory activities comply with current testing methodologies published by regional Pharmacopeia standards (USP/EP and other).
Establish improvement processes and metrics across the department to add value to customers.
Lead complex laboratory investigations, including Out of Specification (OOS) and Out of Trend (OOT).
Interact with Regulators and internal auditors.
Manage the analytical development program.
Foster and drive continuous improvement throughout the lab organization in harmony with business and site objectives.
Optimize and sustain 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.
Manage departmental budget controls (headcounts, expenses & capital) and HR company policy.
Develop strategy and clear operational plans for the department.
Provide leadership to the QC department, supporting and developing reports through coaching, mentoring, appraisals, 1:1s, training, performance management, talent management, and reward and recognition.
Communicate effectively and establish processes for smooth communication within the department, across functions, and across sites.
Ensure two-way communications between Site Leadership and the department.
Ensure proper planning and execution of testing of all samples and materials.
Ensure analytical methods are adequately validated and maintained.
Ensure analytical equipment is adequately calibrated and qualified prior to use and continuously kept in a qualified state.
Ensure stability samples are tested on time and the stability program is adequately managed.
Ensure retention samples are adequately kept and assessed.
Ensure department participation in the site’s internal audit program.
Actively participate in FDA and other regulatory inspections for the site and support the issuance of a timely response to the Agency for any observations.
Approve GMP related documentation such as SOPs, Change Controls, Deviations, Lab investigations, Stability reports, Validation/Qualification documents and Technical Reports.
Approve any changes associated with these documents.

Requirements

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.
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).
English, good oral and written level.
Computer Tools: Word, Excel, Power Point intermediate level.

Skills

Analytical problem-solving
Project management
Leadership
Teamwork
Communication
Conflict resolution
Interaction management
Negotiation
Problem solving
Decision making
Critical aptitude

Location

Work Type

Full-time

Experience Level

8 years of experience in an FDA regulated industry
Minimum of 5 years’ management experience

Education Level

Bachelor’s degree in science or relevant field

Salary/Compensations

$130,355 to $177,757 plus a 12% Performance Bonus

Benefits

Generous 401(k) plan
Tuition reimbursement
Time off programs
6 months paid parental leave
Healthcare programs where the company pays for the majority of your medical coverage for you and your family
Discretionary bonus based on the achievement of key business performance
Other incentive/recognition programs

About the Company

Haleon is a purpose-driven, world-class consumer company putting everyday health in the hands of millions.
Our trusted portfolio of brands includes Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum®.
We have a unique blend of deep human understanding and trusted science.
Our Win as One strategy puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do.
We are driven by an agile, performance-focused culture.

Equal Opportunity

Haleon is committed to mobilizing our purpose in a way that represents the diverse consumers and communities who rely on our brands every day.
We strive to create an inclusive culture where different backgrounds and views are valued and respected.
It is important to us that Haleon is a place where all our employees feel they truly belong.
Personal information shared during the application process is voluntary and used to meet regulatory and reporting obligations and support inclusion and belonging programs.
Personal information provided will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions.
If you are a US Licensed Healthcare Professional, Haleon may be required to capture and report expenses incurred on your behalf in the event you are afforded an interview for employment to ensure compliance with US Transparency requirements.
If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact HR.AmericasSC-CS@haleon.com with the subject line ‘Haleon Careers: Job Accommodation Request’, including your name, contact information, Requisition ID, Job Title, Location, and a description of the accommodation requested.