Product Owner
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
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 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 to as part of the offering.
At Oak Hill, we are the proud manufactures of Sensodyne, Pronamel, Aquafresh and other toothpastes. We would love for you to come join our team!
Are you energized by the opportunity to drive external support and shape product development for our global medicines? If so, this Product Lead Manager role could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
- Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
- Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialization of new products from R&D, and subsequent transfers to other sites. The Product Owner is responsible for the completion of all TRA, MMI (site specific), batch records and recipes for all NPIs and Technical transfers.
- Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
- Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties (primary product owner), assessment of impact of API/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc
- Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D.
- Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
- Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
- Leads Product Technical Review Team (PTRT) if Product Owner for drug product.
- Identifies, develops and trains successors for the role, and coaches others in his/her area of expertise, ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.
- Review opportunities for batch processing improvements and waste reduction. Work with a cross functional team to implement as required.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree
- 5 years minimum formulation development experience within the pharmaceutical industry
- Experience with Good Manufacturing Practices (GMP)
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- PhD in formulation
- Ability to take accountability for formulated product supply from CRO’s.
- Ability to coordinate and influence in a matrixed environment.
- Demonstrated experience leading projects
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 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.
*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.
The health and safety of our employees are of paramount importance. We believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
We have made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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.