Senior Manager, Early Phase Quality Operations

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; escalate significant issues to the 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.