The PositionDirector 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.
Wisconsin pay range
$180,000-$210,000 USD
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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