Quality & Systems Compliance Manager

Haleon • Town of Durham, NY

1d • $130,355 - $175,000

About The Position

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

Requirements

• 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.

Nice To Haves

• 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.

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 in 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

Benefits

• Competitive pay
• Comprehensive benefits program
• Generous 401(k) plan
• Tuition reimbursement
• Time off programs
• 6 months paid parental leave
• Healthcare programs (company pays for the majority of medical coverage for you and your family)
• Discretionary bonus based on the achievement of key business performance
• Other incentive/recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior