A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.
Responsible for managing the Quality Assurance and Quality Control Departments providing support to facilities manufacturing API's, Excipients and/or cGMP raw materials. Assures that systems are in place in all areas of operations to achieve compliance with cGMP requirements.
Represents company in interactions with customers and governmental agencies to ensure regulatory requirements and customer expectations are met. Provides mentoring and development opportunities for both direct and indirect staff to insure adequate number of properly trained individuals are available to take on new challenges as the business grows.
ESSENTIAL JOB FUNCTIONS
Develops, implements, and maintains the Quality Management System (QMS) to be compliant with internal procedures and FDA regulations for Active Pharmaceutical Ingredients, Excipients, and GMP raw materials.
- Manages the development and implementation of validated test procedures, which fulfill cGMP requirements. Also responsible for departments managing the testing of cGMP products and the product Stability Program.
- Responsible for final release of all products, ensuring quality and regulatory requirements are met.
- Provides expert guidance and consultation to operations management in the areas of Regulatory compliance and industry expectations. Ensures plant is managed to ensure regulatory compliance and continued plant profitability.
- Develops and maintains a staff of qualified professionals that monitors, modifies, and reports on the effectiveness of the Quality Management System.
- Manages inspections by regulatory agencies (FDA/EMEA) and acts as the primary contact for regulatory issues for the facility.
- Manages the audit and response process for customer and third part audits, ensuring business requirements are met.
- Leads process improvement initiatives within the Quality Department and institutes programs and projects to improve site’s level of compliance to remain in line with changing regulatory demands.
- Works with Corporate Quality Staff to insure the site Quality System is in compliance with Corporate Quality policies and supports the overall Corporate Quality Systems harmonization process.
- Ensures a safe working environment in Quality Assurance.
- Ensures compliance to the site Validation Master Plan.
- Manages department budget in line with expectations, as well as pursuing cost reductions in all possible areas.
- Final site decision point for all quality related issues.
- Site ISO Management Representative
Who You Are:
Education: Bachelor Degree in a scientific discipline required; Advanced degree strongly preferred.
Experience: Minimum 10 years experience in a Quality environment and minimum 5 years Management experience in a cGMP regulated industry with a Bachelor Degree
Essential and Critical Skills:
- Thorough understanding of cGMP requirements for APIs, Pharmaceuticals, and Biologics.
- Thorough understanding of analytical techniques.
- Strong leadership skills with proven ability to manage a manufacturing site.
- Excellent written and verbal communications skills.
- Ability to act as a mentor to staff and co-workers and act as a proven agent of change.
- Experience in managing inspections by regulatory agencies (FDA, EMEA, etc.).
- Proven team building, mentoring and personnel development skills.
- Thorough knowledge of Project Management and Process Improvement skills. Six Sigma/Lean Manufacturing qualification desirable.
ADDITIONAL LOCAL NEEDS:
- International travel required for vendor/corporate audits, customer technical visits and intra-company visits.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.