What are the responsibilities and job description for the Manager, Quality Engineering (Change Control) position at Arrowhead Pharmaceuticals?
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 Manager, Quality Engineering Change Control, will work within the cGMP-regulated Quality organization to act as the Subject Matter Expert and Owner of the Quality Systems Change Control and Effectiveness Checks. This role will provide quality oversight of, and lead change control activities for: equipment and instruments, computerized systems, product and processes, analytical methods, vendor change management, and supporting regulatory documentation. As part of this oversight, the incumbent will work with cross-functional teams to assess proposed changes, identify the impact to associated systems, and identify necessary actions to implement the changes. This role also will be responsible for managing change completion as measured by change action and change control due dates.
Responsibilities
- Work cross-functionally with stake holders to assess proposed change controls, determine change impact, define action items and effectiveness checks, and track completion of change controls.
- Communicate changes to all relevant stakeholders to ensure proper implementation.
- Monitor and report on change implementation to ensure adherence to business need timelines or regulatory commitments
- Communicates Supplier Notice of Change and coordinates appropriate evaluation
- Provide training on change control within the Arrowhead QMS.
- Function as the change control process owner in the Arrowhead Quality Management System
- Evaluate proposed changes to validated computerized systems
- Provide audit support as the change control subject matter expert
- Support continuous improvement and CAPA efforts within the Arrowhead Quality
- Assist with and approve change control assessments
- Provide final Quality approval of change controls and effectiveness checks.
- Summarize and evaluate change controls in support of annual drug product review and annual quality management review
- Prepare, update, review, and route Arrowhead procedural documents (such as Policies, SOPs, Work Instructions, or Forms) utilizing existing templates.
Requirements:
- Bachelor's degree in an applicable science field.
- Additional Quality related certification desired, CQA, CQMP
- Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with expanding responsibilities related to equipment and/or instrument qualification.
- Working knowledge of overall GMP and/or GLP FDA, EU, and ICH regulations.
- Excellent communication skills and ability to work with a diverse range of professionals
- Highly motivated team player willing to contribute to a growing pharmaceutical organization.
- A detail-oriented self-starter who endeavors to anticipate and resolved problems and seeks opportunities to grow their role and responsibilities at Arrowhead.
- Demonstrated leadership of projects and/or personnel for completed of assigned duties.
- Competent knowledge of and ability to use Microsoft Word and Excel.
- Prior experience with use of an electronic document management system in a regulated environment is preferred.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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