Director, GCP Quality Assurance

Role Summary:

Spyre Therapeutics is seeking an exceptional candidate to join our Quality team. The Director/Sr. Director GCP Quality is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, and communication skills to conduct responsibilities independently.  This role is accountable for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company's Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations).

  Key Responsibilities:

• Provide professional expertise and guidance on GCP, GLP and Good Pharmacovigilance Practices (GPV) regulations and other applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
• Liaise with various Spyre functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance
• Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Spyre policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations
• Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP/GLP/GPV and Spyre policies and procedures. 
• Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP/GLP/GPV; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities
• Lead and support GCP/GLP/GPV health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Spyre
• Analyze, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation
• Collaborate with Quality Operations team to identify and mitigate GCP/GLP/GPV quality and compliance issues with potential impact across multiple programs or functional groups
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Other duties as assigned

Ideal Candidate:

• BA/BS degree, preferably in biological sciences, or related field
• Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry
• Minimum 10 years of GCP-related Quality Assurance or relevant clinical trial and medical device experience
• Extensive knowledge and/or awareness of ICH GCP, GLP and GVP and applicable global regulations and guidance for clinical development
• Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice
• Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical QMS (e.g., Root Cause Analysis, etc.)
• Experience with eDocument Management, Training, CAPA’s, Audit systems and tools 
• Detail oriented with strong written and verbal communication skills
• Ability to work independently with minimal direction, within prescribed guidelines, or as a team member
• Ability to work well in a deadline-driven environment
• Travel may be required up to 15% of the time

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $200,000 to $225,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.