Quality & Compliance
Manager, Quality Assurance
Office Location: Verona, WI
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The purpose of this position within the Quality Assurance department is to support on-going development programs for clinical and commercial drug candidates at Arrowhead. A key function of the position will involve quality oversight functions for external organizations. The candidate will be expected to interact with multiple internal departments and external vendors. The role will involve leadership and development of QA department staff.
Responsibilities
- Management, hiring, and mentoring of QA department staff.
- Participate in meetings with vendors and external organizations as the QA representative.
- Collaborate with, and provide quality support for, other departments (CMC, Project Management, Toxicology, Clinical Operations, Supply etc.).
- Organization and control of quality, compliance, and project related
- Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing
- Monitoring of clinical temperature excursions.
- Auditing of vendor and internal documentation and quality
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
- Write, review, update, approve, issue, and organize applicable Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ).
- Other duties consistent with the position as assigned from time to time.
Requirements:
- Bachelor’s in Chemistry (or related field) with 6+ years of relevant experience
- Excellent communication skills and ability to work with diverse
- Highly motivated team player willing to contribute to a growing pharmaceutical
- A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at
- Experience with development, implementation, and maintaining compliance systems and procedures.
- Demonstrated leadership of projects and/or personnel for completion of assigned
Preferred:
- Advanced degree
- Previous management experience preferred.
- Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC,
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.