Head of Quality Operations
Head of Quality Operations
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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.
Your role
The Head of Quality at the Danvers SingleUse Center of Excellence will develop and lead the Danvers Quality Organization. The Head of Quality will manage a team responsible for Quality Operations Quality Systems and Quality Engineering. In compliance with MilliporeSigma Quality objectives and Operations Vision the Head of Quality will be accountable to apply Quality policies and challenge the Danvers site Quality efficiency and effectiveness. The Head of Quality is a member of the Danvers Operation Management leadership team
Responsibilities:
- Quality System compliance and ISOcertification.
- Quality System management including CAPA deviation change control and audits (internal supplier customer).
- Customer Care activities such as technical visits customer complaints management customer inquiries change notification and field corrective action.
- Supporting 24 x 7 operations by ensuring outgoing Quality meets expectations. Quality Operations includes document control incoming inspection product lot release testing cleanroom environmental monitoring and QA release activities.
- Quality Engineering function including site validation support and new product design assurance
- Danvers Quality System Center of Excellence ensuring central control of the Quality System at the Mobius SingleUse manufacturing facility in China and future Mobius Europe site.
Functional Tasks:
- Be recognized as an expert in identifying and defining Quality expectations of internal and external customers.
- Implement proactive approaches to ensure the right level of competitive advantage through leadership and continuous improvement.
- Develop and implement robust Quality systems and data analysis. Implement systems to increase the speed and quality of key processes and drive business and process improvements with tools like RCA FMEA Quality by Design.
- Report & monitor all Quality metrics at the appropriate frequency
- Identify proactively changes /or trends of customers and develop plans to meet these accordingly.
- Support Product Development Process for the Division to ensure new products are developed robustly in a riskbased approach. Be a strong liaison between the company and various external parties including member of key customer supplier relationship teams and regulatory bodies like FDA ISO etc.
- Ensure that appropriate standards (ISO FDA GMP etc) are followed in the area of responsibility
- Develop the organization to ensure the team is able to achieve both current and future goals through rigorous performance management succession planning and personal development plans.
Who you are
Education and Skills:
- Bachelor of Science in engineering or a sciencebased discipline. Masters Degree in Science or Business is a plus.
- Similar experience and/or similar positioning in Operations environment.
- Strong expertise in Quality Management & Quality Systems
- Solid Project Management skills including the ability to provide strategy priority and direction
- Strong leadership skills including the ability to influence cross functionally
- Ability to work in a crossfunctional environment strong interaction with manufacturing marketing R&D and sales.
- Experience in government regulations customer needs and business needs and translate those needs into programs policies procedures that ensure products and services meet establish Quality standards
- Proven experience in change management intercultural environment and cultural change.
- Experience in Pharmaceutical Biotech Food & Beverage Chemical Medical Devices or Life Science industries
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
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:
Director
Employment Type
Full Time
