greenhouse
Senior Manager, Integrated Quality Operations
Arrowhead Pharmaceuticals
Verona, USA
Full-time
Senior · 10+ years experience
Onsite
USD 150000-165000 / year
Discovered Today
Communication
Key Skills for This Role
Communication
Full Job Posting
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 $150,000—$165,000 USD
- 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.
- California Applicant Privacy Policy
Preferred Qualifications
- Preferred
- Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, etc.
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.
About Arrowhead Pharmaceuticals
Pharmaceutical Manufacturing711 employeesFounded 2003
Public biopharmaceutical company developing gene-silencing RNAi medicines for patients with intractable diseases.
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