Lead, R&D Quality and Compliance, HI Bio

Job Description

As the Lead of R&D Quality and Compliance you will be responsible for HI Bio’s Research and Development Quality Management System (QMS) strategy and execution globally including quality risk management, quality culture and processes, and quality data and analytics. This includes quality and compliance elements covering Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), Good Research Practice (GRP) and Good Pharmacovigilance Practice (GVP).

What You’ll Do:

• Provides global strategic leadership for R&D Quality and Compliance (RDQC) to ensure governance and oversight of R&D’s Quality Assurance processes (i.e. audit strategy/execution, inspection readiness/execution, etc.), assessment of complex quality/compliance issues/risks, evaluation & reporting framework of quality and compliance risks to executive leadership.
• Sets vision for R&D Quality & Compliance team driving value through a risk-based, proactive & preventative approach to quality.
• Accountable for R&D Quality & Compliance workload and resource management, including annual budget management
• Provides the strategic direction for quality leadership in a matrixed/cross functional environment, collaborating to address roadblocks, challenges, resourcing constraints and prioritization of challenges related to R&D Quality and the R&D QMS.
• Chairs select QMS governance boards and quality forums, and drives an aligned escalation of QMS health to senior management and governance boards.
• Develops and oversees framework for the R&D QMS; defines and monitors measurable quality objectives with functions executing R&D activities
• Partners with Quality and Compliance organizations across other functions to enable transparency & escalation of R&D quality and compliance issues as well as supports non GXP quality and compliance efforts that impact R&D.
• Sets risk evaluation strategy and framework on compliance and quality issues with senior leadership which includes enterprise-level R&D metrics and associated standards.

Who You Are:

You have proven experience with overseeing and setting a strategic direction for a quality management system and driving execution, leading change and cultivating networks. You have robust global, health authority experience (inspections/other interactions) and have a strong understanding of regulations across GCP, GVP, GRP and GLP.

Qualifications

• At least 12 years pharmaceutical or biotechnology drug development experience of which 6+ in a quality or compliance related discipline or equivalent quality management activities
• Must have direct GXP QA or Compliance experience, with strong GVP and GCP experience and experience in multiple disciplines
• Ideal candidate as people management experience
• Working knowledge of international GXP regulations and directives, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA) and ICH Guidelines.
• Strong strategic, critical thinking skills with ability to influence senior leadership and ability to manage multiple complex projects simultaneously

This position is Hybrid based and travel to our San Francisco office on a regular basis. Candidates must be within a commutable distance to be considered. For the right candidate we may open to remote hires in the US. 

Additional Information

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission: Caring Deeply, Achieving Excellence, Changing Lives.

Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

The base compensation range for this role is $168,000 to $279,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long