Key Responsibilities:

Process/product Oversight and Knowledge:

• Maintain the oversight of the process of the product(s) assigned 'door to door' at the site (e.g. from raw materials to primary packaging).

• Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer or from development, to date.

• Create and maintain and/or approve product specific risk assessments.

Single Point of Contact for Above Site Product Specific Information:

• Liaise with Global Product Steward at global level and locally with functions (Quality Assurance (QA), Quality Control (QC), Engineering, Regulatory Chemistry Manufacturing & Controls (Reg. CMC), etc.), production management (e.g. Process Support Lead, Facilitator, etc.), shop floor (e.g. Operators, Coordinator, etc.), with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product in constant state of validation.

Continued Process Verification (CPV), Data Trending, and Statistical Analysis:

• Assess CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters (CPPs), In Process Control (IPC) parameters, Quality Attributes, Characteristics of raw materials, etc.) using statistical analysis and conducting regular product specific data trending. Utilize data trending and statistical analysis to:

• Deepen and broaden process understanding and knowledge.

• Detect issues in process capability, such as systematic quality defects.

• Identify trends of process deviations (e.g. deviation with common root cause).

• Issue quarterly/annual data trending report.

• Assist initiating the product-specific monitoring of all critical In Process Controls (IPCs) and release parameters in each laboratory (transfer of the product-specific Quality Risk Analysis). Ensure data and trending is visible and communicated at shop floor level.

New Product Activities:

• Responsible to assure that the design of the manufacturing process outline and batch formula to fit the proposed equipment at the site. Ensure the development activities evaluate the potential failure modes and CPP to confirm criticality and to (if possible) determine failure points or point of diminishing quality. Define process parameter and critical process parameters operating ranges to ensure acceptable critical quality attributes (CQAs).

Investigations/improvement on Product:

• Support and approve Change controls, investigations, CAPAs that potentially impact product quality or the validated manufacturing and packaging process. Assist cross-functional team improvements projects to manufacturing/packaging process. Actively participate and represent their product(s) in the relevant committee where the improvements on weak point products are planned, prioritized, and monitored. Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.

Validation:

• Provide all necessary information to perform the validation documentation, align with stability expert, and QC labs to organize the stability samples. Design, plan, execute validations / verifications protocols, consulting approving and reviewing the process validation master plan, together with the Validation subject matter expert (SME). Defines the manufacturing and packaging process parameters necessary to assure product quality.

Testing Monograph Oversight:

• Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content.

Change Control:

• Participate and/or lead (case by case) the change controls to its products and related processes.

• Ensure alignment of (regulatory) timelines for technical changes (e.g. DS), transfers or launch, major deviations.

Audit Support

• Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit.

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in Science, Technology or Engineering.
• 5+ or more years of experience operating in a complex technical environment.

If you have the following characteristics, it would be a plus:

• Advanced Degree
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Sound experience in data handling and applied statistics.

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.

*LI-Haleon

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.