Document Control Specialist

Haleon; North Carolina; On-site; USD 110,000 - 151,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Parental leave (6 months)

Healthcare coverage

Job summary

Haleon in Durham, New York seeks a seasoned quality systems leader to drive QMS implementation and ensure regulatory compliance across the site. You will guide CAPA processes, risk management, and audits, coordinating with global teams and regulators.

A Bachelor in Pharmacy or related field with 5+ years in quality is required, along with strong English and proficiency in standard office software. The role offers a robust benefits package and opportunity to influence quality culture within a

Qualifications

• Bachelor, Pharmacy or related degree required.
• 5+ years in production or quality with at least 1 year in quality.
• Proficient with standard office software.
• English CET-6 level for reading and speaking.

Responsibilities

• Lead site QMS implementation and ongoing management in compliance with QMS and GMP.
• Drive continuous improvement of the quality system across the site.
• Interact with regulators and internal auditors to ensure compliance.
• Establish measurable improvement processes and metrics across the department.
• Oversee CAPA generation and follow-up, ensuring effectiveness.
• Manage site documentation lifecycle and quality alerts.
• Support site GMP audits and internal audits.

Skills

Quality management

Regulatory compliance

GMP knowledge

Audits

Education

Bachelor in Pharmacy or related field

Tools

Office software

Job description

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

About the role

• Responsible for QMS implementation and development. Ensure site QMS system management.
• Assure all GMP inspection and internal inspection QMS compliance level
• Participate in and where necessary drive the continuous improvement of the quality system throughout the site.

Responsible for the leadership and oversight of the following:

• Conducts all activities and makes decisions that are in accordance with Company Policies, procedures, and Regulatory guidelines, environmental guidelines, as appropriate, etc.
• 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.
• Provide responsibility for other quality, product, and/or compliance activities as assigned.
• Interact with Regulators and internal auditors.
• Responsible for the generation and implementation of Quality Standards and Policies enabling the business to operate within regional quality and compliance standards
• Responsible for departmental budget controls (headcounts, expenses & capital) and HR company policy.

Key responsibilities

• Manage site quality system in compliance with QMS (quality system management) requirement and Chinese GMP to ensure effective QMS implementation.
• Seek improvement opportunity for QMS effective implementation at Site in linkage with OE deployment
• In change of QMS gap analysis and QMS risk identification. In charge of communication QMS with global.
• In charge of QMS training in site and ensure training effectiveness.
• In charge of QMS gap analysis and QMS risk identification and escalation.
• Ensure QMS CAPA could be generated realistically and follow up CAPA completion. In charge of QMS CAPA effectiveness evaluation.
• In charge of the compliance training system to ensure employees are competent and appropriately qualified to perform their jobs and ensuring all internal and external requirements are adhered to.
• In charge of site risk management, organizing risk and compliance review meetings, guiding and reviewing site risk assessment reports, ensuring that risk management processes comply with regulations and ICH Q9 requirements. And maintain close communication with Global team.
• In charge of the management of external documents, quality alerts, and regulatory requirements documents.
• In charge of the documentation lifecycle management of site document management systems, and providing corresponding technical support for electronic document management systems.
• Support site GMP audit and all level of internal audit.
• Manage QMS team, motivate and encourage QMS SMEs.
• Understand and comply with the applicable local regulations of Quality, EHS, Haleon standards for QMS and company policy. Adherence to standard operating procedures
• Other projects and tasks as assigned by the line manager.

Qualifications and skills

• Bachelor, Pharmacy or related.
• More than 5 years production or quality experiences, experiences in Quality area at least 1 year.
• Familiar with the Office software and other professional software.
• English level CET-6 for oral and reading ability.

Preferred

Well occupational moral, Honest, persist in the principles.

High sensitivity of Quality

High ability of communication, coordination, leading and creation.

Good ability of analysis and judgment.

Good ability of report and learning.

Familiar with OE standards will be an advantage

Familiar with Haleon quality organization and QMS.

Familiar with the Haleon report system/measurement system/Audit system

Familiar with relevant National and local quality regulatory requirement

Familiar with Quality system/SOP/Specifications

Familiar with quality tools implementation

The salary range for this position is $110,178 to $151,494.20 plus a 12% performance bonus

Haleon 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 Date

2026-10-12

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

Haleon is a global consumer health company dedicated to delivering better everyday health through trusted brands like Sensodyne, Panadol, and Centrum, prioritizing humanity and sustainability.

Location Town of Durham, New York, United States