A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.
As the Quality Assurance Manager for the Biologics Midwest subcluster, you will have multi-site responsibility for quality assurance aspects of the Quality Management System (QMS) to ensure that processes and procedures are in compliance with ISO 9001, ISO 13485, and current Good Manufacturing Practices (cGMP). The Quality Assurance Manager provides leadership and expertise on quality assurance processes and tools. You will lead the teams that manage specific quality management systems and processes such as Deviation, CAPA, Change Control, Training, Complaint Management, Document Control, and Divisional Policy implementation. In addition, you will have the responsibility to ensure that the sites are in a state of continuous inspection readiness. The Quality Assurance Manager will report directly to the Head of Quality for Biologics Midwest.
Who You Are:Minimum Qualifications:
- Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001, ISO 13485, and cGMP.
- Hire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goals.
- Drive achievement of site vision and goals/objectives.
- Foster best practice sharing across sites.
- Drive risk reduction programs and ensure the application of risk management and sound root cause analysis.
- Analyze and report quality measures, performance trends, and improvements.
- Support the initiation and management of quality improvement plans.
- Provide Quality Management Systems training to site employees as part of the learning management system.
- Review and approve quality documentation such as procedures, deviation/CAPA plans, risk assessments, and change controls to ensure compliance.
- Provide quality assurance support to new product introduction and contract manufacturing activities.
- Bachelor's degree in a scientific discipline or life science-related field and/or certification in Quality Management or related area required.
- Strong knowledge in ISO 9001, ISO 13485, and 21CFR GMP requirements and guidelines.
- Minimum of 8+ years of successful experience in a quality leadership role with successful demonstration of the key quality assurance responsibilities.
What we offer:
- Demonstrated leadership, people development, and coaching.
- Highly developed interpersonal, written, and verbal communication skills.
- Ability to establish collaborative relationships with various departments to deliver on quality commitments.
- Ability to work autonomously, effectively manage time and deliver results on time.
- Strong problem-solving skills.
- Strong computer skills, including Microsoft Office and Quality systems (Trackwise) software.
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.com
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.
Job Requisition ID: 223350
Location: St. Louis
Career Level: D - Professional (4-9 years)
Working time model: full-time
This job has expired.