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
Director of Quality Management Systems (QMS) is responsible for overseeing the GxP QMS to ensure compliance with regulatory requirements, industry standards, and company policies for the development, manufacturing, testing, release and distribution of pharmaceutical products (clinical and commercial).
Director of QMS will lead a team of Quality professionals, provide strategic leadership in QMS development, in partnership with support departments to enhance and drive quality culture and continuous improvement initiatives. Arrowhead Pharmaceuticals is at an inflection point. We are advancing a broad pipeline of RNA-based therapies toward commercial readiness — and we are building and enhancing the quality infrastructure to match. This is not a role for someone who wants to maintain a system. This is a role for someone who wants to build one.
As Director of Quality Management Systems, you will own the QMS architecture that underpins our path to pre-approval inspection (PAI) readiness and beyond. You will report directly to the VP of Quality, operate with real authority, and leave a mark on how quality works at Arrowhead for years to come.
Responsibilities
- Develop, maintain and optimize global QMS strategy and processes based on relevant regulatory requirements and aligned with corporate goals.
- Manage and oversee all aspects of GxP QMS functions for clinical and commercial products, including Document Control and Training; Non-conformance Management and CAPA, Internal QMS Audits, Quality Management Review, and Change and Risk Management.
- Monitor emerging regulatory trends and ensure proactive adaptation of processes changes.
- Lead and support risk assessments using current industry best practices and methodologies.
- Partner with manufacturing, analytical development and quality control, supply chain, regulatory affairs, manufacturing, and clinical and non-clinical development teams to ensure alignment on quality and compliance objectives.
- Identify, assess, and mitigate GxP-related risks across relevant processes.
- Build, mentor, and lead a high-performing QMS team. Foster a culture of quality, accountability, and collaboration within the team and across the organization.
- Strong leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
- Organized, priority-setting, effective written and verbal communication
- Perform additional duties as requested
Requirements:
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field. Advanced degree preferred (PhD, MS, or equivalent preferred).
- 10+ years of experience in the pharmaceutical or biotechnology industry contract manufacturing organization, or contract research organization.
- 6+ years in QMS leadership with demonstrated experience leading a quality system through a clinical-to-commercial transition or pre-approval inspection readiness program.
- Knowledge of GMP and GDP regulations, as well as ICH/FDA, EU MDR, ISO 13485, including experience with development of applicable QMS and regulatory compliance programs.
- Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Strategic thinker with a focus on continuous improvement and innovation comfortable with working in a fast-paced, dynamic environment with evolving priorities.
- Ability for occasional business travel.
- Strong people and team leadership skills.
- Shows broad understanding of the issues relevant to technical/science and business.
Preferred:
- Advanced degree (PhD, MS, or equivalent) in life sciences, pharmacy, chemistry, or a related field.
- Experience supporting or preparing for pre-approval inspections (PAI) or commercial GMP inspections by FDA or EMA.
- Experience with electronic QMS platforms (e.g., Veeva QualityDocs, TrackWise, or equivalent).
- Experience in biologics or RNA-based therapeutic development environments.
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.
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Skills Required
- Bachelor's degree in life sciences, pharmacy, chemistry, or related field
- Advanced degree (PhD, MS, or equivalent)
- 10+ years experience in pharmaceutical, biotechnology, CMO, or CRO environments
- 6+ years in QMS leadership, including clinical-to-commercial transition or PAI readiness
- Knowledge of GxP, GMP, GDP, ICH, FDA regulations, EU MDR, and ISO 13485
- Experience developing and managing QMS functions: Document Control, Training, Non-conformance Management, CAPA, Internal Audits, Change and Risk Management
- Well-developed communication and interpersonal skills with stakeholder influence ability
- Strategic thinker focused on continuous improvement and able to work in a dynamic environment
- Strong people and team leadership skills
- Ability for occasional business travel
- Experience supporting/preparing for pre-approval inspections or commercial GMP inspections
- Experience with electronic QMS platforms (e.g., Veeva QualityDocs, TrackWise)
- Experience in biologics or RNA-based therapeutic development environments
- Current, valid authorization to work in the country where role is located
What We Do
Arrowhead Pharmaceuticals is a clinical stage, Nasdaq listed (ticker ARWR) company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, our 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. Our RNAi-based therapeutics are at the leading edge of genetic-based therapy with the potential to bring life changing treatments for patients. Our Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. The TRiM platform builds on more than a decade of work on actively targeted drug delivery and offers several advantages including simplified manufacturing and reduced costs; multiple routes of administration; and potential for improved safety. Our employees are nimble, science-driven, and innovative professionals. A career at Arrowhead offers the opportunity to collaborate with top notch scientists to rapidly discover and develop RNAi-based therapeutics to add to our growing pipeline. Research and development activities are located in Madison, WI. Our R&D group includes fully-integrated capabilities for chemistry, biology, and toxicology. Madison is an exciting and sophisticated city that includes state government, the flagship campus of the University of Wisconsin, and major research organizations. Our HQ, clinical and regulatory operations are located in Pasadena, CA. Just north of Los Angeles and resting in the foothills of the San Gabriel Mountains, Pasadena is known for its natural scenic beauty, vibrant cultural and academic environment and rich architectural setting.
