Senior Manager - Integrated Quality Operations

The Position

This position leads the Integrated Quality Operations team for Arrowhead's product portfolio and holds day-to-day accountability for quality oversight of programs starting with pre-clinical test article characterization and spanning across early phase clinical development through late phase clinical and commercial supply, including programs where early and late phase/commercial activities run in parallel. The Senior Manager applies phase-appropriate GMP requirements across raw materials, drug substance, drug product, packaging, labeling, storage, and distribution for both internal operations and external suppliers. Core accountabilities include QA release of GMP raw materials and components, product release and stability data review, specification lifecycle management, and subject matter expert ownership of quality events, including deviations, OOS/OOT results, and CAPA.

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 GMP Operations Quality Assurance team supporting early phase, late phase, and commercial programs, including hiring, management, mentoring, performance management, and workload planning.
• Provide GMP quality oversight applying phase-appropriate requirements to programs that span clinical and commercial supply for areas including nonconformances and out of specification results.
• Own QA release of GMP raw materials, including review of supplier documentation and certificates of analysis, incoming inspection and testing records, and compendial and regulatory compliance; make final raw material disposition decisions.
• Own QA review and approval of the release and stability program, including release and stability protocols/reports, QA data review, stability OOS/OOT results, assignment and extension of retest dates and expiry, and stability commitments supporting regulatory filings and ongoing supply.
• Own specification lifecycle management for intermediates, drug substance, and drug product, including creation, review, approval, periodic review, and version control; work collaboratively with the other stakeholders including regulatory, CMC, and analytical development to ensure acceptance criteria are phase-appropriate, tighten appropriately as programs progress, and remain aligned with filed commitments and compendial requirements.
• Serve as the subject matter expert and process owner for quality events, including deviations, investigations, OOS/OOT results, root cause analysis, product impact and quality assessments, CAPA, effectiveness checks, and change control; coach investigation owners, approve investigation quality and conclusions, and escalate significant issues, as necessary.
• Maintain inspection readiness and support health authority inspections and partner audits covering GMP operations for clinical and commercial products.
• Collaborate with, and provide quality support for, other departments (CMC, Manufacturing, Analytical Development/QC, Supply Chain, Regulatory Affairs, Clinical Operations, Project Management, Toxicology, etc.).
• Organization and control of quality, compliance, and project related documentation, including GMP record retention within the electronic quality management system.
• Develop, track, and report quality metrics for GMP operations, including material release, quality event and CAPA aging, and right-first-time performance, 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 as programs progress from clinical to commercial operations.
• Maintain knowledge of current compliance expectations and regulations pertaining to investigational and commercial products (e.g., 21 CFR Parts 210/211, ICH Q1A(R2), Q6A/Q6B, Q7–Q12, EU GMP and applicable Annexes, GDP, and USP/Ph. Eur. compendial requirements).
• 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 supporting GMP operations for clinical and/or commercial products.
• Direct experience with material and product disposition, including raw material release, batch record review, and release of drug substance or drug product.
• Demonstrated experience serving as a quality subject matter expert for deviations, investigations, OOS/OOT results, root cause analysis, and CAPA.
• Experience with specification setting and management and with review and trending of stability data.
• Working knowledge of US and international GMP regulations and guidance applicable to investigational and commercial products, including phase-appropriate application of GMP.
• 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 a commercial launch and/or an NDA/BLA/MAA submission and pre-approval inspection.
• Experience managing quality events through the transition from early phase into late phase and commercial supply.
• Working knowledge of compendial requirements (USP, Ph. Eur., JP) and compendial change monitoring.
• Formal training in structured root cause analysis and investigation methodology.
• Experience with sterile/parenteral drug product and with oligonucleotide, peptide, or biologic modalities.
• Experience with electronic quality management, document control, and laboratory information management systems (e.g., Veeva Vault, TrackWise, MasterControl, LIMS).
• Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, etc.

Wisconsin pay range 150000 - 165000 USD