Location: Warren, NJ

Salary range: $107,945 - $146,043

Hello. We'reHaleon. A new world-leading consumerhealthcare company. Shaped by all of us. Together, we'reimproving everyday health for millions of people. Bygrowing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil,Voltaren, Theraflu,Otrivin, and Centrum - through aunique combination of deep human understanding andtrusted science. What's more, we're achieving it in acompany that we're building together. In an environmentthat we're co-creating. And a culture that's uniquelyours. Care to join us. It isn't a question.

Job Purpose:

Provide end to end quality and compliance oversight for the portfolio of CMs (contract manufacturers) to assure delivery of high-quality products to our consumers, such that we maintain the trust of consumers and regulators.

Key Responsibilities:

• E2E management of daily operations for key CMOs within the assigned portfolio including Deviation Management, Change Controls, CAPAs, Audits (L2/L3/L4) & Inspection readiness, Laboratory OOSs (Analytical & Micro), Complaints, Stability Program, Health Authority correspondence, Validation Documentation, Performance Management (KPIs/Scorecards), Quality Improvement Plans, CMO Documentation approvals (Specs & Masters), Registration related requests, QRI/Q.Alerts, PPRs, Product Disposition decisions, and proactive compliance such as eDM, Data Integrity program, eCM, smart stability, etc.

• Be the point of contact for the Contract Manufacturer and build strong relationships with internal and external partners to ensure quality principles are upheld by all functions within GSK and by the CMOs; partner with Supply Chain, Technical, Procurement, LOC / LOC QA, Site QA, and other stakeholders / experts within GSK.

• Ensure CMO facilities and systems meet and maintain cGMP & compliance requirements; develop, negotiate and enforce Quality Agreements.

• Ensure delivery of expeditious and thorough quality-issue resolution pertaining to critical/major deviations (e.g., Escalations regarding PIRCs & Recalls or significant supply impact) and/or project related escalations.

• Act as PIRC Secretary for Product Incident and Review Committees (PIRCs) by helping the PIRC Chair managing inputs (investigation, risk assessment, SME advice) and outputs (product hold and/or market action decisions). Act as PIRC Chair as trained, when required.

• Provide expert advice on cGMP/regulatory compliance requirements and standards to assure fit for purpose interpretation and application of regulations at CMOs and within GSK CH; assume role of SME based on area of expertise.

• Ensure risk management methodology is embedded in the management of quality issues and proactive detection of compliance gaps which could lead to adverse impact on the safety and efficacy, product integrity, and regulatory compliance of GSK products; utilize GSK tools of RMS, Quality Risk Model for CMOs, and risk management framework.

• Utilize the Strategic Resource Allocation (SRA) and CMO Operational model for prioritization and efficient management of time and energy, while being effective at providing optimal level of quality oversight to CMs.

• Provide input into sourcing strategies and CMO selection decisions.

• Provide support into local Quality Councils, provide input into higher tier Quality Councils and provide input into business review meetings at CMOs.

Job Qualifications:

• Bachelor's degree in science or engineering

• 8 years in pharmaceutical QA, QC, Manufacturing or Technical, especially experience with site quality remediation and inspection readiness.

• Broad & Advanced technical and regulatory knowledge of current analytical and manufacturing technologies for various dose forms and regulations (dietary supplements / nutritionals, medical devices, cosmetics, food, medicinal drugs, etc.)

• Higher order critical thinking, logical reasoning, reading comprehension and interpretation skills (application of cGMPs).

• Prior experience in auditing or working at a site or laboratory.

• Prior experience interacting with Health Authorities.

• Lean Six Sigma certification (Green Belt / Black Belt / Master Black Belt) / continuous improvement exposure.

• Excellent project management, prioritization and organization skills.

• Ability to travel 40%

Preferred Skills:

• Master's degree in science or engineering

• Line management / matrix leadership experience is desirable.

Diversity, Equity and Inclusion

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 flex the way we work so we can be at our best, where possible, and with agreement between line manager, team and individuals. We acknowledge not all colleagues can flex locations depending on their roles and that we don't have all the answers. Yet.

Care to join us. Find out what life at Haleon is really like 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.