Product Lifecycle Specialist

About the role

The Product Lifecycle Specialist ensures all Haleon Quality Management System activities and decisions are in accordance with the product lifecycle for the site. This includes the redaction of Periodic Product Review as per annual plans, site-wide review of change controls, oversight of applicable regulatory changes, and management of complaints for the site.

The purpose of this role is also to identify:

• areas of product improvement with relevant stakeholders for necessary investigation and implementation of associated CAPA in compliance with local regulatory & Quality requirements
• areas where our processes can be simplified and adapted the type of product manufactured, with an objective to make compliance easier.

Role Responsibilities

Periodic Product Reviews (PPRs)

• Compile PPRs in line with the procedures and established timelines. Escalate any issues that may prevent that PPRs are completed in time and with the necessary quality to meet regulatory expectations and global internal requirements.
• Collect data from for raw materials, excipients, packaging components, finished product, and stability.
• Retrieve data from SAP and/or communicate with the pertinent site groups to determine the batches manufactured, packaged, or released during the annual review period, as well as the associated active and inactive ingredients utilized for the production process.
• Provide an overall assessment of PPR data elements and make recommendations when gaps or trends are identified; perform any data trending needed for the PPRs and identify any out of trend issues (lower Process Capability etc.) with a product with relevant functions (Technical, Stability, Production, Compliance, QA Operations, QA Compliance and QC teams) to facilitate investigation and resolution of PPRs.
• Raise deviation and CAPA, if the technical gaps observed during PPR analysis.

Change Control

• Facilitate the change control program by evaluating and helping to process site change requests.
• Collaborate with departments to ensure smooth and effective implementation of changes.
• Track and facilitate changes through the change control process; report on their status and effectiveness.

QRI & Regulatory Dossier

• Monitor changes in regulations, guidelines, and enforcement actions globally to anticipate and respond to regulatory challenges effectively.
• Author and update regulatory dossiers in accordance with regulatory authority and Haleon guidelines.
• Work with Supplier Quality Lead to ensure confidentiality agreements are in place with third parties.

Complaints Management

• Conduct thorough investigations into complaints, collaborating with quality assurance, production, and other relevant departments to identify root causes.
• Ensure complaint handling process complies with regulatory requirements, including FDA, and other relevant guidelines.
• Maintain accurate records of all complaints and investigations and prepare detailed reports for internal and external stakeholders.
• Analyze complaint trends and data to identify areas for process improvement and implement corrective and preventive actions. Present this data in Quality Council.
• Assist in internal and external audits by providing documentation and evidence of complaint handling processes and resolutions.
• Collaborate effectively and establish processes to ensure smooth communication within the department, across functions, and across sites. Ensure two-way communications between Site Leadership and the department.
• Approve/review/author GMP related documentation. Approve changes associated with these documents.
• Other duties as assigned.

Why you?

Basic Qualifications:

• High School Diploma.
• 3 years of experience in quality systems and/or compliance in a Good Manufacturing Practices (GMP) facility.

Preferred Qualifications:

• Bachelor’s or Master’s degree in Life Sciences.
• Pharmaceutical Manufacturing experience.
• Analytical laboratory experience.

Location: This position is based in St. Louis, MO.

This job posting closes on: September 19th, 2025.

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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.

Accommodation Requests

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 us by sending an email to HR.AmericasSC-CS@haleon.com. Please include the following in your email:

• Use subject line: ‘Haleon Careers: Job Accommodation Request’
• Your Name and contact information
• Requisition ID and Job Title you are interested in
• Location of Requisition (city/state or province/country)
• Description of specific accommodation you are requesting
• Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

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.