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QA Manager (API and Excipients Cluster)
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.
As the Quality Manager for the APIs, Excipients and Cell Media technology cluster you will be accountable for the coordination of quality assurance and Quality related activities in the cluster in connection with the respective business and operations units and ensuring that each of the manufacturing sites have programs in place to meet regulatory and quality compliance relevent to the product claims, site registration and Life Science requirements.
- Develops and implements programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. Implements policies, procedures and methods to check product, material, components and/or operational quality and improve same.
- Provides direction through managers to execute functional business plans and contribute to the development of quality strategy.
- Business partner for Site Heads of Quality focusing on the quality status and performance of the Operations site network by supporting the development a culture of quality and continuous improvement
- Ensures quality of products, services and suppliers in compliance with external regulations and customer quality requirements
- Contributes to the future direction and quality strategy for the cluster sector
- Responsible for supporting day-to-day management, setting objectives, coaching and developing employees.
- Supports negotiations and influences stakeholders internally and support the Quality Services team who interact with strategic customers for quality requirements, incident handling and quality performance, and support interaction with authorities as required by the regulatory management
- Engage and support the resolution of complex or unusual business problems applying advanced analytical thought and judgment.
- Ensures site inspection readiness.
- Reviews requests for major changes and PDP/TDP gate reviews and makes recommendations.
- Support the initiation and review quality improvement plans.
- Lead and manage critical quality incidents, interact with authorities with the support of the regulatory team
- Supports the governance to the local Quality Unit, site manager, cluster head to ensure quality of products, services and suppliers in compliance with external regulations and customer quality requirements.
Who You Are:
- Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required.
- Highly conversant in GMP requirments and knowledge of Regulatory agencies practices and guidelines.
- Minimium of 5+ years of successful experience in a quality leadership role capacity with successful demonstration of the key responsibilities as presented above. Previous life science industry is preferred.
- Demonstrated experience working in a highly matrixed, GMP manufacturing setting.
- Demonstrated leadership, people development and coaching.
- Requires prior managerial auditing experience
- Strong written and verbal communication skills.
- Strong problem solving skills.
- Strong computer skills, including word processing, and Quality systems databases.
- Knowledge of pharma/biotech bulk and finished product manufacturing
- Knowledge of ICH Q7A, 21CFR and Eudralex GMP regulations
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.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.