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. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

About the role

As an Operational QA Manager, you will be responsible for designing and managing experiments using various instrumentation and analytical techniques in support of method development and ensuring compliance with Regulatory expectations and Haleon internal requirements.

Role Responsibilities

• Ensure that product released is manufactured and/or packaged in compliance with regulatory agencies' requirements and company standards.
• Provide Quality leadership directly and indirectly through the Quality Operations to the Production, Technical, Engineering, Supply Chain, Quality Control and GMP units to ensure their activities are in compliance with regulatory agencies' requirements, company standards, and site procedures (SOPs).
• Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
• Lead complex and critical deviation including PIRC management process.
• Interact with Regulators and internal auditors.
• Provide responsibility for other quality, product, and/or compliance activities as assigned.
• Maintain departmental budgets and HR company policy.
• Develops the strategy and clear operational plans for the department.
• Provides effective leadership, resource and support to ensure that products accepted by the facility and/or released for sale have been manufactured and packaged in accordance with cGMP and applicable laws.
• Proactively influences the Operational Team by interpreting regulatory policy, establishing processes and providing cGMP and compliance guidance.
• Provides leadership to the OQ department with responsibility for supporting and developing reports.
• Acts as a coach or mentor using appraisals, 1:1's, training and development, performance management, talent management and reward and recognition.
• Communicates effectively and establishes processes to ensure smooth communication within the department, across functions and across sites. Ensures two-way communications between Site Leadership and the department.
• Ensures department's L1 audits are performed and supports/host L2, L3 and L4 audits.
• Actively participate in FDA and other regulatory inspections for the Lincoln Site; support the issuance of a timely response to the Agency for any observations.
• Approves GMP related documentation such as SOPs, CCRs, Deviation, Validation/Qualification documents and Technical Reports. Approves any changes associated with these documents.

Why you?

Basic Qualifications:

• Bachelor's degree in science or relevant field and 8 years of experience in a regulated industry

Preferred Qualifications:

• Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
• Demonstrate initiative and analytical problem-solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level.
• Requires project management and leadership skills.
• Ability to work well under high pressure and deadlines.
• Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies.
• Excellent verbal and written communication skills required.
• Conflict resolution and interaction management skills required.

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.