Arrowhead Pharmaceuticals, Inc. is a Nasdaq listed (ARWR), Russell 3000 company that develops medicines to 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’s dynamic and innovative environment offers our employees the opportunity to advance revolutionary treatments for serious and intractable diseases. Our employees are smart, creative professionals who work collaboratively to meet our business and scientific challenges. Arrowhead’s R&D facility is located in the Research Park in Madison, WI.
The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical and clinical drug candidates at Arrowhead. A key function of the position will involve creation and maintenance of document control systems supporting Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). The candidate will be expected to interact with multiple internal departments, as well as assist with quality oversight functions for external organizations.
Key Duties and Responsibilities:
- Contribute to the development of quality and compliance systems to support pre-clinical and clinical phase drug development and research.
- Writing, review, change control, approval, issuance, and organization of Standard Operating Procedures (SOPs).
- Organization and control of quality, compliance, and project related documentation.
- Support utilization of an electronic document management system (Veeva QualityDocs).
- Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing records.
- Support CMO/vendor selection and qualification and on-going performance tracking.
- Development, tracking of, and leading employee training programs and files.
- Issuance, review, tracking, and completion of internal deviations and CAPAs.
- Auditing of vendor and internal documentation and quality systems.
- Coordination of biweekly meetings for the Quality/Compliance Team, including preparation of meeting agendas and minutes.
- Assisting with generation, tracking, monitoring, and reporting of key quality metrics.
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
- Collaborate with, and provide quality support for, other departments (CMC, Project Management, Toxicology, Clinical Operations, etc.).
- Participate in meetings with vendors and external organizations as the QA team representative.
- Assist with protocol preparation and review of equipment/instrument and method qualification.
- Other duties consistent with the position as assigned from time to time.
- Excellent communication skills and ability to work with diverse professionals.
- 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.
- Experience with development, implementation, and maintaining compliance systems and procedures.
Physical or Other Requirements:
- This position requires the ability to sit and/or stand on a regular basis in execution of required duties. Requires spending significant portion of time when executing duties working at a computer and typing on a keyboard. Specific vision requirements of this job include close vision, color vision, and the ability to adjust focus.
- Minimum of 8 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization.
- Working knowledge of GMP and/or GLP regulations, as well as ICH/FDA guidance documents, including experience with development of compliance programs.
- Prior experience with use of an electronic document management system in a regulated environment
- Understanding of document control requirements in a FDA regulated organization.
- Competent knowledge of and ability to use Microsoft Word and Excel
- Ability for occasional business travel.
- Bachelor’s degree in a science field. Advanced degree preferred.
All applicants must have authorization to work for Arrowhead in the U.S.
Please send resumes to firstname.lastname@example.org. Include a cover letter that highlights your qualifications and matches our requirements.