Quality Assurance Compliance Manager
Quality Assurance Compliance Manager
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1 Vacancy
Job Description
A career with MilliporeSigma is an ongoing journey of discovery: our 57000 people are shaping how the world lives works and plays through next generation advancements in healthcare life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA Darmstadt Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your role
The Quality Assurance Compliance Manager is responsible for effectively managing all Quality Assurance aspects of the Quality Management System (QMS) to ensure that process and procedures are in compliance with cGMP and other regulations and standards as appropriate for Active Pharmaceutical ingredient (API) manufacture. Reporting to the Site Head of Quality and in partnershipwith the QA Operations Leader and QA Customer Leader the Quality Assurance Compliance Manager creates a positive image of Millipore Sigma through communication and interaction with key stakeholders including employees customers LS quality organization and business partners vendors and appropriate governmental and regulatory authorities.
The Quality Assurance Compliance Manager provides leadership and expertise on quality compliance processes and tools.You will lead a team that manages specific quality management systems and processes such as Deviation Management CAPA Management Change Control Risk management Data integrity Quality Management and Annual Product Reviews Supplier Quality Management Quality Agreements Training Field Corrective Actions Management of regulatory and Customer Audits Complaint Management and Divisional Policy Implementation. Responsible in collaboration with the site personnel for ensuring that the site is in a state of continuous inspection readiness.
Roles and responsibility:
The Quality Assurance Compliance Manager possesses detailed knowledge of cGMP. Highly developed interpersonal written and verbal skills including the ability to influence and drive improvement to Madison/Verona quality management system. They must be able to establish strong collaborative relationship with all departments within the organization to deliver on quality and regulatory commitments and have the ability to work autonomously effectively manage time and deliver results on time.
Who you are
The requirement of the role includes:
- Lead and develop a team of qualified professionals to manage all Quality Assurance aspects of the Quality Management System (QMS) to ensure that process and procedures are in compliance with cGMP for API manufacture in a Contract manufacture organization
- Maintain and communicate a clear quality vision for the safe efficient and compliant production of APIs and other GMP compounds.
- Develop and implement programs to establish and maintain quality standards of existing products as well as developing programs to focus employees on quality improvement.
- Ensures the organization has an Inspection Ready program with personnel preparation for hosting inspections and inspection follow up.
- Owner of the Sites Quality and Regulatory Heat Map with responsibility to drive the risk reduction programs and support the initiation and review of quality improvement plans.
- Provide GMP training and governance to the site and responsible for the site training program as executed in the Learning management system (LMS).
- Ensures that Deviation CAPA and Change control programs follow adherence to GMP and closure times as executed in TrackWise.
- Owner of the Data integrity plan and as per project plan.
- Responsible for the implementation of policies procedures and methods to check product material components and/or operational quality and ensures implementation of corporate policy and procedures.
- Manage customer complaints and associated reports.
- Oversee external regulatory and customer audit programs
- Prepare and Conduct QMR and APR appropriate to GMP and product requirements.
- Frequent interaction with internal teams to support product license and regulatory submissions with the regulatory affairs group.
- Maintain the Approved Supplier List (ASL) including updating and reviewing performance of vendors and ensuring Quality Agreements with vendors are established and maintained.
- Provide compliance review for documentation including change controls deviations validation documentation SOPs and specifications.
- Management of Supplier Quality Agreements.
- Provide Quality Compliance support to new product introduction (NPI) activities.
- Reviews requests for major changes and PDP/TDP gate reviews and makes recommendations.
- Management of critical quality incidents and Field corrective actions (FCA) and product returns as necessary interact with authorities with the support of the regulatory team.
- Collate and deliver weekly and Monthly KPIs to Management.
What we offer: With us there are always opportunities to break new ground. We empower you to fulfil your ambitions and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious Apply and find more information at https://jobs.vibrantm
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race color religion age sex sexual orientation national origin ancestry disability military or veteran status genetic information gender identity transgender status marital status or any other classification protected by applicable federal state or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring promotion compensation benefits discipline termination and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner Legal or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Required Experience:
Manager
Employment Type
Full Time
