Senior Manager, Supply Chain Quality Assurance

Senior Manager, Supply Chain Quality Assurance page is loaded## Senior Manager, Supply Chain Quality Assurance remote type:
Remote locations:
Remote time type:
Full time posted on:
Posted Yesterday job requisition :
JR000598

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline.

We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
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* Position Summary:

** The Senior Manager, Supply Chain Quality is primarily responsible for management and oversight of quality processes overseeing packaging / labeling, distribution, QP oversight for clinical and commercial supplies, and supportive operations in compliance with Good Manufacturing / Distribution Processes.
** Essential Job Functions and Responsibilities:
** These may include but are not limited to:
* Perform batch record review, and disposition related activities for Clinical and Commercial Supplies
* Coordinate and manage Quality Events (Deviations, CAPAs) with CMOs and escalate them to QA management
* Oversee QA Packaging / Labeling Operations and distribution for Crinetics products
* Review and approve labeling artwork for clinical and commercial product
* Partner with Clinical Trial Supply organization to develop schedule and strategy  for packaging and release activities including Qualified Person (QP) oversight.
* Represent QA in internal and external team meetings
* Support QA team on internal and external GMP/GDP audits
* Support QA management on compiling Quality associated metrics
* Lead / Support QA management on field related activity such as complaints, Field Alerts, Recall / Withdrawal, and notification to regulatory agencies.
* Perform impact assessment and disposition for supplies that are subjected to temperature excursion
* Write and review Standard Operating Procedures
* Write and approve internal investigations, as applicable
* Compile metrics of Batch Disposition, deviations, CAPAs, as applicable
* Supports GMP QA operations and overall QMS processes, as appropriate.

Other duties as assigned.
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* Education and Experience:

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* Required:

* Bachelor’s degree in chemistry/Engineering/any scientific discipline
* 12 years of relevant experience in a GMP environment that constitutes Drug Substance, Drug Product, and Packaging and Labeling
* Solid dosage experience is preferred, however, experience in other dosage forms with relevant experience is acceptable
* Prior experience with Electronic QMS systems (Veeva preferred)
* Demonstrated knowledge of FDA/EMA/ICH standards and regulations
* Demonstrated knowledge of Risk Assessment and Root Cause Analysis (5 WHYs, FMEA)
* Demonstrated ability to effectively organize, and work in a fast-paced environment
* Demonstrated ability to function individually and in a team environment
* Working knowledge of relevant manufacturing equipment and operations and analytical testing and quality control oversight. PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
* Windows, MS Office (Outlook, Word, Excel, PowerPoint).  Knowledge of other software required: e-QMS (e. g. Veeva), ERP systems, Interactive Response Technology (IRT) for Clinical Supplies, and Serialization.
** Physical Demands and Work Environment:
** Physical

Activities:

On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required.…