Senior Manager, Integrated Quality Operations
- Compensation
- Not disclosed
- Location
- Verona, Wisconsin, United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Full time
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.
Nice to have
- 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.
Full description
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 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.