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.
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are seeking a qualified Quality Engineer Manager who will be responsible for overseeing staff responsible for Facility support and building strong relationships within the organization and our clients as part of a dynamic Contract Manufacturing Organization. This role will be overseeing the QA team providing facility support including, but not limited to, validation, line clearances, vial inspection/labeling AQL’s, investigation support and review/approval of controlled documents.
As a Quality Engineer Manager, you will be the primary Quality contact at the Carlsbad Site for internal QA support of facilities in our contract manufacturing business including developing and driving appropriate performance KPIs, managing timelines and working with various stakeholders to successfully deliver customer deliverables, while helping to maintain our facilities in a state of inspection readiness. You will effectively lead, initiate and drive change for the Carlsbad Site while interfacing with internal and external clients and develop a best in-class Facility support QA group.You will oversee a wide variety of Quality Assurance activities required to support the Carlsbad Site including the Warehouse, Production, and QC/PD Laboratories.The QA manager is responsible for ensuring all of the activities follow established SOPs and regulations as well as meeting current compliance requirements(cGMP). Additional responsabilities of the role:
- Leads, manages and develops the Facility support QA team to support the daily operations of the Carlsbad Site
- Ensure that Quality metrics are met and continually improving, and that metrics are communicated throughout the site as appropriate.
- Develop strong working relationships with internal groups such as Production, Quality Control, and Engineering
- Performs analysis and interpretation of data in support of events and CAPAs
- Review/Approve protocols and final reports as QA
- Support/ participate in new product transfers into Manufacturing. Ensures adherence to the Product Development Process (PDP)
- Liaise with appropriate cross-functional departmental areas to determine root cause for non-conformances
- Create/Revise/Approve SOPs and other GMP documentation
- Maintains high level knowledge of lab procedures and assays
- Contributes ideas and suggestions to improve Quality systems, Compliance and Safety
- Coaches/ trains others on Quality Systems and Inspection preparation
- Leads internal and external interactions such as client and regulatory audits/inspections, meetings, teleconferences as QA representative
- Responsible for employee coaching and development, determining employee responsibilities, evaluating and managing performance as appropriate
- Identify, recruits, and retain top-notch talent
- Promote a culture of continuous improvement within Quality Assurance; act as champion on initiatives to drive improvement in quality and client services
- Comply with company EH&S requirements. Promote a safety first culture
- Performs other duties as assigned
Who You Are:
- BS degree or higher in a Life Science discipline or equivalent
- Minimum of five (5) years of leadership/supervisory experience
- Minimum of five (5) years of experience in cGMP Quality Assurance environment. CMO Experience is a plus
- Experience in Quality Systems, Validation, Auditing and Regulatory Inspections
- Strong Foundation in quality systems supporting ISO 9001 certification as well as FDA and EU regulations
- Expert knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals
- Experience with Lean Manufacturing and Continuous Improvement concepts
- Strong Interpersonal skills and ability to work with a variety of personalities at all levels within the organization
- Detail oriented with strong written and verbal communication skills
- Ability to work independently within prescribed guidelines or as a team member
ADDITIONAL LOCAL NEEDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties, the employee is:
- Constantly required to sit and reach to use computers and other office/lab equipment
- Constantly required to view objects at close and distant ranges
- Frequently required to communicate with others
Employee frequently works in a professional office environment and production areas with computer equipment, machinery, tools, and moderate amounts of noise and activity. Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct off- shift, weekend, and overtime duties may be required as assigned by the manager of the employee.
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!
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