A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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.
As the Head of Quality Control you will be accountable for management of a GMP Quality Control department supporting custom API manufacturing and drug product testing according ICH Q7A and 21CFR regulations. You will oversee the Quality Control activities associated with product testing, stability program management, method validation and transfer and cleaning validation.
- Management and development of Quality Control department, consisting of 7 QC groups totaling 50+ employees
- Accountable to meet business and quality performance metrics
- Define and implement programs to establish and maintain quality systems, and quality standards of existing products and services, as well as developing programs to focus employees on quality improvements
- Develop policies, procedures and methods to check and improve product, material, components, processes and/or operational quality
- Participate in the investigation of QC test issues. Also, assists Manufacturing with investigations and troubleshooting issues. Assists process improvement projects. Detect quality problems w/in the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify it to management
- Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes
- Manage and prioritize test scheduling so products are released in a timely manner
- Develop and manage the department budget and capital expenditure budget Interact with internal and external customers on regular basis
- Represent QC matters during regulatory agency and customer inspections
- Other duties as required
Who You Are
- Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required. Master's degree in a scientific discipline or related discipline desired but not required.
- 3-5+ years of successful experience in a 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 team building skills.
- Requires prior managerial experience.
- Strong written and verbal communication skills.
- Strong problem solving skills.
- Strong computer skills, including word processing, and Quality systems databases.
- Knowledge of basic laboratory techniques.
- Knowledge of FDA practices and guidelines.
- Knowledge of pharma/biotech bulk and finished product manufacturing and analytical testing requirements.
- Knowledge of analytical instrumentation and software, and medical devices.
- 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 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.