Group Manager, Quality Control
About The Position
The Group Manager, Quality Control will provide operational and people leadership for Arrowhead’s QC function, supporting our mission to develop innovative RNAi‑based medicines. This role is responsible for ensuring timely, high‑quality analytical testing to support clinical and commercial programs, driving compliance with GxP expectations, and strengthening QC’s infrastructure as Arrowhead continues to scale. The Senior Manager will oversee day‑to‑day lab operations, lead a growing QC team, support laboratory expansion initiatives, and serve as a key partner across Manufacturing, QA, Supply Chain, and other internal stakeholders. Fast‑paced, science‑driven environment dedicated to delivering innovative RNAi therapeutics. May require occasional extended hours based on operational needs.
Requirements
- Bachelor’s degree in chemistry, Biology, Life Sciences, or related field required, advanced degree preferred.
- 8+ years in GMP QC laboratory, with 3–5 years in a leadership role.
- Biotech/pharmaceutical experience required; experience with oligonucleotide or biologics testing strongly preferred.
- Strong working knowledge of analytical methods including HPLC/UPLC, LC-MS, GC, UV, and other relevant analytical technologies.
- Demonstrated experience with compendial methods: pH, osmolality, appearance, UV, endotoxin, bioburden, environmental monitoring.
- Proficient and demonstrated experience with analytical instrumentation, test methodology/validations/transfers, data acquisition systems, and typical cGMP policies/practices.
- Strong understanding of data integrity, GxP, and regulatory expectations.
Responsibilities
- Provide daily oversight of QC testing activities to ensure accurate, timely release, stability, in‑process, environmental monitoring, raw material testing, microbial testing and characterization testing in support of Arrowhead’s development and manufacturing programs.
- Manage sample scheduling, resource planning, and prioritization to support program timelines and ensure operational continuity.
- Lead, coach, and develop QC analysts and supervisors, fostering a collaborative, high‑performance culture aligned with Arrowhead values.
- Drive accountability through clear goal setting, regular feedback, and effective performance management.
- Support the scaling and maturity of the QC organization and succession planning.
- Oversee execution and troubleshooting of a diverse set of analytical methods, including but not limited to:
- Ensure analysts are trained, qualified, and operate with consistency and accuracy.
- Lead, author, and drive timely closure of laboratory investigations, including atypical results, Out‑of‑Specification (OOS), Out‑of‑Trend (OOT), and analytical deviations.
- Ensure investigations meet regulatory expectations for scientific rigor and data integrity.
- Troubleshoot complex analytical test failures and partner with SMEs and analytical development to identify root causes and corrective actions.
- Perform and interpret data trending and statistical analysis to identify method, instrument, or process trends, using tools such as control charts, control limits, and trend reports.
- Partner closely with QA to support audit readiness, participate in inspections, and implement improvements that enhance Arrowhead’s compliance posture.
- Lead QC functional activities related to lab expansion, including equipment installation, qualification (IQ/OQ/PQ), layout planning, and workflow optimization.
- Support continuous improvement and readiness for system upgrades and enhancements.
- Serve as QC’s primary interface with Manufacturing, QA, Supply Chain, Validation/CSV, Analytical Development, and Program Leadership.
- Strengthen communication pathways to ensure QC requirements and capacity constraints are clearly understood across stakeholders.
- Drive improvements to QC processes, systems, and documentation that enhance efficiency, data integrity, and scalability as Arrowhead progresses toward commercial readiness.
- Implement and track QC performance metrics, KPIs, to identify trends and guide decision‑making. KPIs for turnaround times, deviations, testing cycle times, equipment uptime, and trend analysis.
- Support readiness for commercial manufacturing and increasing analytical complexity
Benefits
- Arrowhead provides competitive salaries and an excellent benefit package.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
