About the role

The Quality System Manager ensures the site has robust efficient Quality System to maintain and continuously improve compliance with the regulatory requirements of all markets to which the site supplies products.  Critical in providing compliance governance of site-wide organizational systems critical to maintain business operations, including enterprise resource planning (ERP), Automation, Electronic Batch Records (EBR) and Laboratory Management Systems (LIMS) etc.

Role Responsibilities

Ensures site Quality Systems are robust, effective, and compliant with regulatory requirements of all markets to which the site supplies products, especially in the following programs and activities:

• Change Control program oversight including the interphase with Regulatory Affairs and related functions - Review and approval of process, product and facility change proposals, including trending and assessment of impact of changes over time.
• Document Management - Management of the documentation lifecycle process including procedures, Release specifications and laboratory methodology.
• QA Validation Oversight - Review and approval of Site Validation Master Plan, all product and non-product validation plans and reports including facilities, cleaning, equipment, CSV and QC equipment’s.
• Periodic Product Review Oversight – Reviews and approval of periodic product reviews reports on a timely manner following the annual schedule.
• Quality Standards and Policies implementation
• Ensure Supplier Quality practices are executed throughout the functional roles within the organization.
• Leads efforts is remediating critical supplier non-conformances.
• Actively partners with senior stakeholders at site to drive CI culture and partnership with key suppliers.
• Material Certification Process, Product Components and Finished Products Risk Assessments (BSE/TSE, GMO, Allergen, Residual Solvents, etc.)
• Data System aligned to software application of QC equipment, automation, and standalone equipment.
• Ensure Haleon Consumer Healthcare Quality standards are met while delivering robust oversight of Product Lifecycle
• Provides guidance and direction to all-training practices at site to ensure quality compliance is met
• Constantly challenges the effectiveness and simplicity of the Quality Systems to ensure efficiency and user-friendliness.
• Support the goals and objectives of the site Quality Unit and the site.
• Network and liaise as appropriate with other Quality professionals within the wider Quality team and in their support of campus operations.
• Participates in Inspection Readiness and DI Gembas
• Supports QA operating budgets for headcount & capital expenditures

Why you?

Basic Qualifications:

• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical or a related field scientific field)
• 5+ years' experience in a process, manufacturing, project, or R&D engineering position
• Experience in Pharmaceutical/FMCG or other regulated industry
• Experience working in a manufacturing environment, including manufacturing process and equipment.

Preferred Qualifications

• Influence and Vision – The candidate must have demonstrated confidence in challenging stakeholders and influencing senior leaders, creating a commanding vision for the future state and ‘what good looks like.’
• Business-oriented /External perspective - The candidate will have a Supply Chain background, and the ideal incumbent would have Senior Site (SLT level) or functional leadership experience. Recent experience in FMCG operations-type roles would be desirable.
• Business Partner – The Candidate must have excellent interpersonal and networking skills to enable effective and influential internal and external communication.
• Finance Acumen – The candidate must understand P&L management to support COGS and product margin improvements.
• Self-Directed and Entrepreneurial – While working as part of a local team, the candidate must be able to work autonomously and set their own direction aligned with Global and Regional Technical team goals.

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.  The salary range for this role is $130,355.00 to $175,000 annually plus 18% Performance Bonus.

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.