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Manager, Quality Assurance (Commercial)

At Lonza, we invest in great people.

We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

Job Description Summary

This position is responsible for ensuring cGMP compliance during the commercial production, testing, release and distribution of batch viral (BV) products.

Responsible for the supporting regulatory or customer inspections, representing the Quality Assurance Department.

Manages the oversight of batch record and APS development, deviations, OOS, CAPAs, technical investigations and batch release related to batch viral products.  Working knowledge and experience in aseptic drug product manufacturing regulations is required.  Experience in quality oversight of aseptic manufacturing.

Key Responsibilities


* Manage the Quality Assurance BV Operation Teams.

Develops and plans departmental goals, establishes timelines and monitors progress and completion.

Oversees commercial batch release. 


* Provides oversight of aseptic operations, including supporting QA on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements.

Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.


* Provides direction for deviations and complaint investigations; Managing deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved.


* Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications.

Ensures process is efficient.


* Supports regulatory or client audits as BV subject matter expert.

Qualifications


* Bachelor’s degree in life sciences required.

Preferred area of study:  Life Sciences


* At least 8 years of GMP experience in commercial biologics manufacturing or equivalent including at least 3 years in a QA supervisory or management role.   Working knowledge of aseptic processing experience required.


* Experience with oversight of aseptic processing and the associated international aseptic processing regulations.


* GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Hu...




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