Quality
Associate Director, Quality Engineering
Office Location: Verona, Wisconsin, United States
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
Provide strategic leadership to manage and advance Quality Engineering (QE) elements, including the systems and processes for change and risk management; asset lifecycle management; facility, utility, and equipment commissioning, qualification, validation (CQV); process validation lifecycle and annual product reviews; cleaning validation and environmental monitoring. Drive system harmonization, compliance, and operational excellence in partnership with cross-functional stakeholders and in support of both clinical and commercial pharmaceutical and combination products. Lead and mentor staff.
Responsibilities
- Provide leadership and oversight of QE elements, including change and risk management; asset lifecycle management; facility, utility, and equipment CQV; process validation lifecycle and annual product reviews; cleaning validation and environmental monitoring.
- Ensure robust systems are maintained to support both clinical and commercial programs, in compliance with global regulatory requirements and industry guidance.
- Develop, coach, and mentor staff to ensure growth, maturity, and efficiencies as well as operational excellence and high-quality outcomes.
- Develop, revise, and maintain policies, procedures, and work instructions to support the growth and maturity of QE systems and processes.
- Support the development, evaluation, and implementation of QMS tools and workflows to increase compliance and efficiency.
- Develop, analyze, and report QE metrics and key performance indicators to senior leadership.
- Augment and maintain training programs for personnel working with QE systems and processes.
- Provide subject matter expertise and support for QE program elements and strategy during regulatory inspections and partner audits.
- Monitor global regulations, emerging guidance, and best practices through active engagement with relevant professional organizations (e.g., ISPE, PDA).
- Foster a culture of quality, collaboration, and accountability within QE and across the organization.
- Perform additional duties as requested.
Requirements
- Bachelor's degree in science, engineering, or a related technical discipline.
- Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including at least six (6) years in a leadership role in a commercial manufacturing environment with increasing responsibility.
- Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Proven experience administering, enhancing, and maintaining QE elements and the associated systems and processes.
- Proven ability to build effective partnerships to advance quality and compliance objectives, demonstrating strong organizational, planning, and prioritization skills.
- Highly motivated, hands-on leader with a focus on continuous improvement and innovation, who endeavors to anticipate and resolve problems.
- Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels.
- Ability for occasional business travel.
Preferred
- Advanced degree preferred.
- Certification or formal training in quality engineering, validation, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent).
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.