Product Lifecycle Specialist

Socket.dev; Oak Hill (WV); On-site; USD 79,000 - 130,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Paid parental leave

Healthcare coverage

Discretionary bonus

Job summary

Haleon seeks a QA/Regulatory Specialist to oversee the site product lifecycle, including PPR redaction, change control review, stability programs, and complaints handling. You will collaborate with cross-functional teams to drive CAPA implementation and ensure compliance with GMP and quality policies.

The role requires a Bachelor's in Pharmacy/PharmD or science and 5+ years in similar roles; US experience preferred.

Qualifications

• Bachelor’s Degree in Pharmacy, PharmD or Science related.
• 5+ years of experience in a similar role.

Responsibilities

• Follow quality system and procedures for PPR in compliance with global SOP requirements.
• Compile PPRs in line with site procedures and timelines.
• Collect data, perform review, and incorporate PPR data into reports.
• Retrieve data from VQMS and communicate with site groups for investigations, CAPA, and trends.
• Retrieve data from SAP and communicate with site groups to determine batches manufactured/released.
• Escalate issues affecting PPR completion and quality.
• Provide overall assessment of PPR data and identify gaps or trends; perform data trending.
• Peer review PPRs written by other PPR Specialists.
• Identify out-of-trend issues to facilitate investigation and resolution in QMS.
• Maintain and archive PPR reports in VQDocs.
• Raise deviation and CAPA for technical gaps observed in PPR analysis.
• Comply with GMP, Quality policies, and related regulatory requirements.

Skills

Quality systems

PPR knowledge

CAPA handling

Data trending

Veeva QMS familiarity

SAP experience

Education

Bachelor’s Degree in Pharmacy/PharmD/Science

Tools

Veeva QMS

SAP

VQDocs

Job description

About the role

Oversight of 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 stability programs 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 requirement. And areas where our processes can be simplified and adapted the type of product manufactured, with an objective to make compliance easier

Role Responsibilities

• Follow quality system and procedures for PPR in compliance with global Standard Operating Procedure requirements.
• Compile PPRs in line with the site’s procedures and established timelines.
• Collect data perform review and incorporate PPR data elements into the PPR reports as per the established PPR annual schedules/Plan.
• Retrieve data from VQMS and/or communicate with the pertinent site groups for all investigations, CAPA, and trending records pertaining to raw material, excipients, packaging components, finished product and stability acquired within the annual review period.
• 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.
• 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.
• 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, where applicable.
• Perform peer review of PPRs written by other PPR Specialist Quality Technical writers.
• Identify any out of trend issues (lower Process Capability etc.) with a product with relevant functions (Technical, Stability, Production, Compliance, QA Operations, QS and QC department) to facilitate investigation and resolution of PPRs in Veeva QMS.
• Maintain and archive PPR reports and supporting documentation in VQDocs.
• Raise deviation and CAPA, if the technical gaps observed during PPR analysis.
• Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and Corporate Guidelines.

Why you?

Basic Qualifications:

• Bachelor’s Degree in Pharmacy, PharmD or Science related.
• More than eight (5) years of experience in a similar role

Preferred Qualifications

• Has basic general technical knowledge, and specific discipline knowledge.
• Have good verbal and written skills. Can articulate issues and solutions to the team. Can produce effective project reports and presentations.
• Can effectively interact and collaborate with team members. Demonstrates respect for others. Encourages team participation

The salary range for this position is from $79,000 to 130,351.11 plus an 8% Performance Bonus.

Benefits

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

2026-10-19

Equal Opportunities

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.

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 [e-mail]. 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

Please note: Resumes, CVs, or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.