Crinetics
pharmaceutical
SeniorManager,SupplyChainQuality
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“Senior Manager, Supply Chain Quality at Crinetics. Skills: management and oversight of quality processes, packaging / labeling, distribution, QP oversight for clinical and commercial supplies, supportive operations. 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”
What You'll Achieve.
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.; Compile metrics of Batch Disposition, deviations, CAPAs, as applicable
Industry & Context.
Risk Assessment; Root Cause Analysis; 5 WHYs; FMEA; impact assessment
Travel: You may be required to travel for up to 10% of your time., Physical Activities: On a continuous basis, sit at desk for a long period of 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., Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
What They're Looking For.
Must Have
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, 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).
Nice to Have
Solid dosage experience is preferred, Prior experience with Electronic QMS systems (Veeva preferred), Knowledge of other software required: e-QMS (e. g. Veeva), ERP systems, Interactive Response Technology (IRT) for Clinical Supplies, and Serialization.
What You'll Do.
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
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
Compile metrics of Batch Disposition
Supports GMP QA operations and overall QMS processes
How You'll Work.
Team & Collaboration
Represent QA in internal and external team meetings; Partner with Clinical Trial Supply organization; Coordinate and manage Quality Events (Deviations, CAPAs) with CMOs; escalate them to QA management; Support QA management; function individually and in a team environment
Communication Scope
communicate through written means
Process & Methodology
Develop schedule and strategy for packaging and release activities
Full Job Description
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. **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
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