WI3835978

1

First Shift (Day)

40

JOB REQUIREMENTS: Work Location: Madison, Wisconsin Shift: No
Department: LS-SC-POWQD Madison & Verona QA Group 3 Recruiter: Paul
Therrien This information is for internals only. Please do not share
outside of the organization. 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 partnership
with 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. Minumum Qualifications: \* 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 Preferred Qualifications: \* 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).
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,
benefi \*\*\*\*\* APPLICATION INSTRUCTIONS: Apply Online:
https://www.aplitrak.com/?adid=YmJnZW5lcmljLjkwNTAzLjg3NzBAZW1kbWlsbGlwb3JlY29tcC5hcGxpdHJhay5jb20

Attn: Human Resources - EMD MILLIPORE
6000 N Teutonia Ave
MADISON, WI 53715