Company:
Haleon
Location: Bern
Closing Date: 21.10.2024
Job Requirements / Description
Quality Assurance & Compliance Manager
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locations: Switzerland - Nyon
time type: Full time
posted on: Posted Yesterday
job requisition id: 525366
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.
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
The Quality Assurance & Compliance Manager is responsible for ensuring the Haleon Quality System (HQS) is effectively implemented and maintained at the Nyon site. Acting as the Single Point of Contact (SPOC) with the Global Quality Organization, this role oversees the deployment and compliance of various quality processes, risk management, and key performance indicators (KPIs). The position involves extensive collaboration across all site departments and grades to uphold quality standards. Additionally, this role manages the site's documentation and training programs, ensuring adherence to regulatory requirements and fostering continuous improvement in quality practices.
Key Responsibilities
Haleon Quality System Champion
Ensure full compliance with the Haleon Quality System (HQS).
Communicate QMS updates to SMEs and stakeholders.
Define subject matter experts for each Global Quality Policy and Process.
Conduct gap analyses, risk assessments, and action plans.
Monitor and report HQS implementation effectiveness.
Serve as HQS expert during audits and inspections.
Support the Permanent Inspection Readiness (PIR) program.
Participate in HQS Community of Practice.
Risk Management Process Owner (RMPO)
Deploy the Risk Management Process at the site.
Lead risk escalation processes and represent the site at EU RMCB.
Provide support for the Risk Management System.
Serve as RMS expert during audits and inspections.
Quality Systems
Provide weekly and monthly KPIs for site activities and Quality Dashboard.
Ensure quality system processes are in place and align with QMS requirements.
Assess Quality Alerts/Bulletins and ensure CAPAs are implemented.
Serve as Quality Systems expert during audits and inspections.
Coordinate Change Control process and manage the Change Control Committee.
Documentation
Oversee the site’s documentation program for SOPs, forms, protocols, and reports.
Training
Design and maintain comprehensive training programs for compliance and priority initiatives.
Partner with SOP owners and PIR SMEs for training applicability.
Continuously improve site-based qualification processes.
People Management
Manage a team of direct reports, including independent contributors and managers.
GMP and HSE
Ensure compliance with all GxP standards and HSE requirements.
Escalate significant GxP and HSE issues.
Qualifications and skills
Essential
University degree in Quality Assurance, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent scientific field.
Minimum 7 years in the pharmaceutical industry within quality assurance.
Experience in auditing activities and being a certified auditor.
Safety, Quality, Results, and Customer-oriented mindset.
Previous people management experience (direct or indirect).
Fluency in French and English.
Excellent knowledge of GMP and regulatory expectations.
Proven interpersonal, communication and leadership skills.
Ability to influence and motivate people.
Role model in GxP, HSE, and Haleon values.
Please save a copy of the job description, as this may be helpful to refer to once the advert closes.
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.
#J-18808-Ljbffr
locations: Switzerland - Nyon
time type: Full time
posted on: Posted Yesterday
job requisition id: 525366
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.
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
The Quality Assurance & Compliance Manager is responsible for ensuring the Haleon Quality System (HQS) is effectively implemented and maintained at the Nyon site. Acting as the Single Point of Contact (SPOC) with the Global Quality Organization, this role oversees the deployment and compliance of various quality processes, risk management, and key performance indicators (KPIs). The position involves extensive collaboration across all site departments and grades to uphold quality standards. Additionally, this role manages the site's documentation and training programs, ensuring adherence to regulatory requirements and fostering continuous improvement in quality practices.
Key Responsibilities
Haleon Quality System Champion
Ensure full compliance with the Haleon Quality System (HQS).
Communicate QMS updates to SMEs and stakeholders.
Define subject matter experts for each Global Quality Policy and Process.
Conduct gap analyses, risk assessments, and action plans.
Monitor and report HQS implementation effectiveness.
Serve as HQS expert during audits and inspections.
Support the Permanent Inspection Readiness (PIR) program.
Participate in HQS Community of Practice.
Risk Management Process Owner (RMPO)
Deploy the Risk Management Process at the site.
Lead risk escalation processes and represent the site at EU RMCB.
Provide support for the Risk Management System.
Serve as RMS expert during audits and inspections.
Quality Systems
Provide weekly and monthly KPIs for site activities and Quality Dashboard.
Ensure quality system processes are in place and align with QMS requirements.
Assess Quality Alerts/Bulletins and ensure CAPAs are implemented.
Serve as Quality Systems expert during audits and inspections.
Coordinate Change Control process and manage the Change Control Committee.
Documentation
Oversee the site’s documentation program for SOPs, forms, protocols, and reports.
Training
Design and maintain comprehensive training programs for compliance and priority initiatives.
Partner with SOP owners and PIR SMEs for training applicability.
Continuously improve site-based qualification processes.
People Management
Manage a team of direct reports, including independent contributors and managers.
GMP and HSE
Ensure compliance with all GxP standards and HSE requirements.
Escalate significant GxP and HSE issues.
Qualifications and skills
Essential
University degree in Quality Assurance, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent scientific field.
Minimum 7 years in the pharmaceutical industry within quality assurance.
Experience in auditing activities and being a certified auditor.
Safety, Quality, Results, and Customer-oriented mindset.
Previous people management experience (direct or indirect).
Fluency in French and English.
Excellent knowledge of GMP and regulatory expectations.
Proven interpersonal, communication and leadership skills.
Ability to influence and motivate people.
Role model in GxP, HSE, and Haleon values.
Please save a copy of the job description, as this may be helpful to refer to once the advert closes.
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.
#J-18808-Ljbffr
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