Quality & Systems Compliance Manager

GSK

Not Interested
Bookmark
Report This Job

profile Job Location:

Oak Hill, OH - USA

profile Yearly Salary: $ 130355 - 175000
Posted on: 4 hours ago
Vacancies: 1 Vacancy

Job Summary

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now its time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose to deliver better everyday health with humanity at the heart of everything we do. It unites us inspires us and challenges us to be better every day driven by our agile performance-focused culture.

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 equipments.
  • 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:

  • Bachelors 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 $130355.00 to $175000 annually plus 18% Performance Bonus.

Benefits

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.

Job Posting End Date

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.

During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.

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 Haleons compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please contact us by sending an email to Please include the following in your email:

Use subject line: Haleon Careers: Job Accommodation Request

Your Name and contact information

Requisition ID and Job Title you are interested in

Location of Requisition (city/state or province/country)

Description of specific accommodation you are requesting

Please note: Resumes CVs or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.


Required Experience:

Manager

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.Our trusted portfolio of brands i...
View more view more

About Company

Company Logo

About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

View Profile View Profile