Senior Manager, Early Phase Quality Operations

Arrowhead Pharmaceuticals, Inc.; Madison (WI); Presencial; USD 130.000 - 180.000; Jornada completa

Descripción de la vacante

Arrowhead Pharmaceuticals, Inc. seeks a Senior Manager, Quality Operations to lead QA for its early-phase clinical programs. This onsite role in Verona, WI oversees day-to-day GMP quality across drug substances, products, packaging, labeling, storage, and distribution, ensuring compliance for preclinical to Phase 2 supplies.

You will manage the QA staff, collaborate with CDMOs/CMOs and internal partners, and drive CAPA, deviations, and change controls while maintaining inspection readiness.

Formación

• Bachelor's degree in a science field and 10+ years of QA experience in pharma/biotech.
• Experience supervising external manufacturing and testing partners.
• Solid knowledge of US and international GMP regulations for investigational products.
• Demonstrated leadership and people-management experience preferred.
• Experience implementing and maintaining quality systems and CAPA processes.

Responsabilidades

• Lead the Operational Quality Assurance team, including hiring, mentoring, and workload planning.
• Serve as QA owner for external partners (CDMOs/CMOs, labs, suppliers) for early phase studies.
• Provide GMP oversight of internal operations supporting early phase material, manufacturing, lab, warehouse, and supply chain.
• Review and approve master and executed batch records, labeling, COAs, and testing reports.
• Disposition of drug substance/product for early phase use in accordance with specifications and IND/CTA/IMPD.
• Oversee deviations, investigations, CAPA, and change controls; escalate to Director as needed.
• Support vendor qualification and requalification activities.
• Coordinate quality aspects of test article characterization throughout the supply chain.
• Assist with clinical supply lifecycle, retention samples, and complaints as needed.
• Monitor storage and distribution events for investigational product.

Conocimientos

QA leadership

GMP oversight

Vendor management

Regulatory compliance

Cross-functional collaboration

Educación

Bachelor's degree in a science field

Herramientas

Veeva Vault

MasterControl

Descripción del empleo

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

This position leads the Quality Operations for Arrowhead's early phase clinical programs and holds day-to-day accountability for quality oversight of both internal operations and external partners. The Senior Manager provides phase-appropriate GMP oversight across drug substance, drug product, packaging, labeling, storage, and distribution activities supporting pre-clinical test article as well as first-in-human through Phase 2 clinical supply. Core accountabilities include management of batch record review and investigational product disposition, quality event and change management, clinical distribution related activities, QP support for product supplied to studies outside the US, and inspection readiness.

The candidate will be expected to interact with multiple internal departments, external vendors, and partners, and will lead, develop, and plan capacity for the QA staff supporting these activities.

This role is full-time onsite, 5 days a week in Verona, WI.

Responsibilities

• Lead the Operational Quality Assurance team supporting early phase clinical programs, including hiring, management, mentoring, performance management, and workload planning.
• Serve as the primary QA point of contact and oversight owner for external partners, including CDMOs/CMOs, contract testing laboratories, clinical packaging and labeling suppliers, clinical supply depots and distributors supporting early phase studies.
• Provide phase-appropriate GMP quality oversight of internal operations supporting early phase clinical material, including manufacturing, laboratory, warehouse, and supply chain activities.
• Review and approve internal and vendor generated documentation, including master batch records, executed batch records, clinical label text and labeling, specifications, certificates of analysis, qualification protocols and reports, stability data, and testing records.
• Perform final review and disposition (release/reject) of drug substance, drug product, and finished packaged investigational product for early phase clinical use, in accordance with approved specifications and the applicable IND/CTA/IMPD.
• Assist with quality event management for internal and external early phase operations, including deviations, investigations, OOS/OOT results, root cause analysis, CAPA, effectiveness checks, and change control; elevate to Director, Operational Quality.
• Support vendor selection and qualification, requalification, and disqualification as needed as an Operational Quality technical subject matter expert.
• Provide quality leadership for test article characterization and early phase clinical materials throughout the supply chain, including coordination with internal owners and stakeholders related to clinical releases.
• Assist with clinical supply lifecycle activities, retention samples, product complaints, and returned or destroyed clinical material, as an Operational Quality technical subject matter expert.
• Monitor and disposition clinical temperature excursions and other storage, shipping, and distribution events for investigational product.
• Collaborate with, and provide quality support for, other departments (CMC, Manufacturing, Analytical Development/QC, Supply Chain, Regulatory Affairs, Clinical Operations, Project Management, Toxicology, etc.).
• Develop, track, and report quality metrics for early phase internal and external operations, and present quality performance and risks to management.
• Write, review, update, approve, issue, and organize applicable Procedural Documents (SOPs, WIs, Test Methods, Policies, Forms, etc.), and drive continuous improvement of quality systems to support phase-appropriate compliance across a growing early phase portfolio.
• Support the quality aspects of program progression from early phase into late phase development, including technical transfer support and handoff of quality history and open events to the late phase/commercial quality team.
• Maintain knowledge of current compliance expectations and regulations pertaining to early phase drug development and investigational product supply (e.g., 21 CFR Parts 210/211, FDA cGMP guidance for Phase 1 investigational drugs, ICH Q7, Q9, and Q10, and EU GMP requirements for investigational medicinal products).
• Other duties consistent with the position as assigned from time to time.

Requirements

• Bachelor's degree in a science field and 10+ years of pharmaceutical or biotechnology quality assurance experience, including early phase clinical GMP operations.
• Direct experience providing QA oversight of external manufacturing and testing partners, including batch record review and product disposition.
• Working knowledge of US and international GMP regulations and guidance applicable to investigational products, including phase-appropriate application of GMP.
• Demonstrated experience managing deviations, investigations, CAPA, change controls.
• Experience with development, implementation, and maintaining compliance systems and procedures.
• Demonstrated leadership of projects and/or personnel for completion of assigned duties.
• Excellent communication skills and ability to work with diverse professionals, including the ability to represent Quality with external partners and senior management.
• Highly motivated team player willing to contribute to a growing pharmaceutical organization.
• A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead.
• Ability to travel domestically and internationally up to 20% for partner oversight and audits.

Preferred

• Advanced degree in a science field.
• Previous people management experience, including hiring and development of QA staff.
• Experience supporting IND/CTA/IMPD submissions and first-in-human study starts.
• Experience supporting test article characterization.
• Experience supporting QP release and clinical trial supply to studies outside the US.
• Experience with sterile/parenteral drug product and with oligonucleotide, peptide, or biologic modalities.
• Experience with electronic quality management and document control systems (e.g., Veeva Vault, TrackWise, MasterControl).
• Experience supporting the transition of programs from early phase into late phase development.
• Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, etc.

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.