Senior Manager, Quality Management System Programs presso Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals · Verona, Stati Uniti d'America · Onsite
- Senior
- Ufficio 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
Work cross-functionally to drive and champion projects related to continuous improvement of the systems, processes, and functions comprising the GxP Quality Management System (QMS), while ensuring compliance with regulatory requirements, industry standards, and company policies in support of the development, manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). Provide expertise on the collective systems comprising the QMS, including the technical functions within Quality Engineering (QE).
Responsibilities
- Coordinate and facilitate stakeholder involvement as systems are continuously monitored and improved to augment compliance and increase efficiencies.
- Identify, champion, and drive improvements to streamline and upgrade the QMS processes in the following areas:
- Document Control & Training: EDMS/EQMS, document lifecycle management, training program design and administration
- Conformance & Continuous Improvement: deviation and OOS investigations, product complaint management, product recall, CAPA, internal auditing
- Change & Risk Management: design of change and risk management framework and application of methodologies
- Quality Engineering: asset lifecycle management; facility, utility, and equipment commissioning, qualification, validation (CQV); process validation lifecycle and annual product reviews; cleaning validation and environmental monitoring; computer system validation and assurance
- Develop, define, support, review, augment, and/or approve a variety of controlled documents, including quality system and technical documents.
- Lead the QMS team in the application of project management and project execution methodologies with a focus on prioritization and resource management.
- Support the QMS team with the development of registers, schedules, metrics, and dashboards as well as mechanisms for tracking and reporting.
- Maintain project plans and project metrics and ensure visibility within the QMS team and to stakeholders.
- Foster a culture of quality, collaboration, and accountability within the team and across the organization.
- Perform additional duties as requested
Requirements:
- Bachelor's degree in life sciences, pharmacy, chemistry, or related field.
- 8 years of experience in the regulated pharmaceutical and/or biotechnology industry, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility.
- Full knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
- Demonstrated skills in the areas of project management, organization, and execution as well as priority setting.
- Proven experience developing and/or improving QMS, QE, and compliance programs.
- Highly motivated, strategic thinker 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.
- Previous experience with the use of electronic document / quality management systems (EMDS / EQMS).
- Ability for occasional business travel.
Preferred:
- Advanced degree in life science.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
