Quality Control Manager
MilliporeSigma

Job Info

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A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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 QC Microbiology Manager, will be responsible for managing Microbiology Laboratory that supports the Carlsbad Viral Vector Manufacturing (CLD-VVM) facility in accordance with cGMP guidelines. This includes developing and driving appropriate performance KPIs, managing timelines and working with site stakeholders to successfully deliver customer deliverables while helping to maintain our production environment in a state of readiness. This role will work successfully, strategically, and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. Additionally, ensure QC Laboratory compliance pertaining to the following regulatory agencies, such as: FDA, EMA, and the ability to follow ISO/EP/ICH and other related guidelines requirements, where applicable. This role also requires to: lead, manage and develop the team that supports the daily operations of the quality control group. This position requires working with external entities (clients and testing laboratories) and provide technical expertise within the context of defining the problem statement, assessing the impact, identifying root cause, and determining corrective actions. Off-shift, weekend, and overtime duties may be assigned by the Head of Quality Control.

Who you are:

Minimum Qualifications:

• BS/Master's degree or higher in a scientific discipline.
• 10+ years of experience leading a quality control organization
• Good understanding of governmental regulatory guidelines requirements relating to the manufacturing of biologics and pharmaceuticals
• Great Technical expertise in the following areas: Microbiology/Environmental Monitoring (EM) and BioChemitry
• Performing product inspections and facility inspections
• Able to travel nationally and or internationally
• Meet all pre-established testing requirements as set by MilliporeSigma
• Ability to perform moderate physical activities

Preferred Qualifications:

• Ph.D. degree in a scientific discipline
• 7+ years of experiencesupporting client audits and regulatory inspections
• 4+ years of Contract Manufactured Organization (CMO) experience
• 3+ years of experience identifying, communicating, investigating, and driving quality system events to completion
• Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
• 5+ years of experience working in a Cleanroom environment
• Experience performing internal and external audits
• Good communication and customer service skills required
• Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
• Ability to develop/optimize new processes and procedures
• Assume responsibility for compliance with safety guidelines
• Ability to work additional hours and weekend
• Ability to work, communicate well with internal and external departments

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.

Job Requisition ID: 229566

Location: Carlsbad

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.