Senior Manager, Supplier Quality

Arrowhead Pharmaceuticals•Verona, WI

8h•$145,000 - $170,000

About The Position

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 Senior Manager, Supplier Quality Management is responsible for leading and overseeing all supplier quality activities to ensure compliance with applicable regulatory requirements, company quality standards, and global GxP expectations. This role provides strategic and operational leadership for qualification, monitoring, and continuous improvement of suppliers, contract manufacturers (CMOs), contract testing laboratories, and material suppliers supporting pharmaceutical development and commercialization. The candidate will be expected to interact with multiple internal departments and external vendors. The role will involve leadership and development of QA department staff.

Requirements

Bachelor's degree in science field.
Minimum of 8+ years of experience in pharmaceutical or biotechnology quality, with 5+ years in supplier quality.
Strong working knowledge of FDA, EMA, ICH, GxP, and GDP regulations.
Demonstrated leadership experience managing teams and cross-functional stakeholders.
Excellent communication skills and ability to work with diverse
A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead

Nice To Haves

Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, etc.

Responsibilities

In collaboration with Business Stakeholders and Supplier qualification and auditing function, develop, communicate, and drive a proactive Supplier Quality Management oversight program for Arrowhead.
Lead the Supplier Quality Management Program, providing direction, mentorship/development, and performance management for supplier quality team members.
Act as the Quality leader in internal and supply chain discussions and contribute to cross-functional initiatives involving Supply Chain, Procurement, Manufacturing, Legal and Regulatory Affairs in decision-making to ensure proper Supplier selection and sourcing (throughout entire product life cycle)
Establish and maintain supplier qualification and requalification programs for raw materials, APIs, excipients, packaging, CMOs, and service providers.
Measure, maintain, analyze and communicate Supplier KPIs, risks, and planned actions, and drive continuous improvements efforts at suppliers for improvement.
Implement Supplier KPIs (key performance indicators) and actively contribute to the internal Quality Management Review and external Business Review meetings.
Manage the SCARs and Supplier Change Notification Programs and ensure effective and timely assessment and resolution of the proposed changes.
Support regulatory inspections by providing supplier quality documentation and serving as a subject matter expert during audits and inspections.
Organization and control of quality, compliance, and project related
Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
Write, review, update, approve, issue, and organize applicable Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ).
Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
Other duties consistent with the position as assigned from time to time.