Team Lead, Quality Assurance bei Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals · Verona, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Verona
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 & 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
The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. Key functions of the position will involve people management and QA review of complex internally generated manufacturing data and associated documents within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Team Leader is expected to interact with multiple internal departments.
Responsibilities
- Participate in meetings as the QA team representative as needed.
- Manage and mentor direct reports.
- Collaborate with, and provide quality support for, other departments (Manufacturing, QC, Project Management, Analytical Development, etc.)
- Writing, review, change control, approval, issuance and organization of procedural documents, and controlled documents.
- Support utilization of an electronic document management system (Veeva Quality) for, but not limited to, electronic batch disposition and release, quality events, and updating of procedural documents.
- Independently review and approve internally and externally generated documentation including, but not limited to, validations, stability/release data, manufacturing data, and associated reports, certificates of analysis, and batch records.
- Perform evaluation of facilities for compliance and cleanliness through room release and QA on the floor activities as needed.
- Independently assess and approve investigations, deviations, and other quality events (QE) as needed.
- Organization and control of project related documentation.
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
- Assist with Good Documentation Practices, Good Manufacturing Practices (GMP), and data integrity training as needed.
- Support manager with day-to-day activities.
- Additional duties as assigned.
Requirements:
- Bachelor's degree in a science discipline, or equivalent required.
- 6 years of experience working in a regulated environment with preference to quality assurance auditing and/or manufacturing experience.
- Excellent written and verbal communication skills and ability to communicate effectively with internal and external parties.
- Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best in class quality assurance protocols.
- Highly motivated team player willing to contribute to a growing pharmaceutical organization.
- Ability to work independently and manage priorities within a fast-paced environment.
- A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead.
- Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
- Understanding of document control requirements in an FDA regulated organization.
- Ability for occupational business travel.
Preferred:
- Additional Quality related certifications.
- Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15).
- Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
- Prior experience with use of an electronic document management system in a regulated environment.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
