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.
The Manager of QA Systems is responsible for oversight of the Quality Management Systems at a site that manufactures custom Active Pharmaceutical Ingredients (API) in accordance to ICH Q7 and cGMP regulations. In support of site wide objectives, this role will manage a QA team responsible for creating processes and maintaining adherence to quality systems such as change management, supplier quality, complaint management, applications for document management, training, deviation/CAPA management, audit management for regulatory agencies, customers, corporate and internal, and general validation guidance on cleaning, equipment and process activities.
You will engage with cross functional teams to develop Quality strategies and support continuous improvement activities. This role requires decision making ability and leadership in the context of quality systems, people development and corporate/site priorities.
- Implement and execute procedures to assure compliance with regulatory requirements and internal policies.
- Maintain and communicate a clear quality vision for the safe and efficient production of APIs and other GMP compounds.
- Contribute to the determination of trends and metrics reported during Quality Management Reviews
- Recognize areas of quality systems that exhibit an opportunity for improvement (ex. Documentation management, Complaints, Training, etc.) based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems.
- Key leader in regulatory agency inspections, acting as inspection host or liaison point with regulatory agencies as necessary.
- Drive Quality system process improvements throughout the site and enable replication of good practices between sites.
- Mentor employees in meeting or exceeding expected job requirements, by ensuring skills and knowledge development occurs to allow employees to maximize performance in current positions.
- Some travel may be required to attend conferences, meet with customers and collaborate with other MilliporeSigma sites.
Who you are:
- Bachelor of Science Degree in Biology, Chemistry or related Technical Physical Science.
- 5+ years progressive experience in GMP Pharmaceutical Manufacturing environment.
- 2+ years managing individuals and a proven ability to develop employees.
- Knowledgeable of current cGMP Manufacturing standards
- Knowledge of regulatory compliance requirements and current guidance for Pharmaceutical/Biological manufacturing (FDA, EMA).
- Strong organizational skills, excellent verbal and written communication skills, and demonstrated leadership ability are required.
- Must be able to provide presentations regarding overall quality systems to customers or potential customers.
- Must be able to assess quality systems, evaluate quality systems for conformance to corporate and regulatory guidance, and proficiently discuss quality systems with customer representatives.
- Masters Degree in related discipline preferred.
- Demonstrated track record of organizational skills and attention to details.
- Strategic thinking at a department level.
- Ability to translate complex issues and accomplishments into language and messaging of general interest.
- Passion for support of an engaged and change-agile culture.
- Commitment to quality and customer service.
- Excellent computer skills including experience with Word, PowerPoint, Excel.
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.