Director, GCP Quality Assurance

Gh Gruppe; United States; Remote; USD 200,000 - 225,000; Full time

Job summary

An established industry player in biotechnology is seeking a Director of GCP Quality to lead Clinical Quality Assurance efforts. This pivotal role involves managing audits, ensuring compliance with Good Clinical Practice (GCP), and overseeing quality assurance for clinical development programs. The ideal candidate will possess extensive experience in GCP and related regulations, along with strong leadership and communication skills. Join a dynamic team where you can contribute to meaningful advancements in medicine while enjoying a competitive compensation package, unlimited PTO, and opportunities for professional growth. This is your chance to make a significant impact in a fast-paced environment!

Benefits

Unlimited PTO

Performance bonus

Equity grant opportunities

Health benefits

Retirement benefits

Company-wide shutdowns

Professional development opportunities

Remote working environment

Qualifications

• 10+ years of experience in GCP-related Quality Assurance or clinical trials.
• Extensive knowledge of ICH GCP, GLP, and GVP regulations.
• Strong leadership and communication skills required.

Responsibilities

• Lead Clinical Quality Assurance activities for clinical development programs.
• Manage audits, quality issues, and regulatory inspections.
• Develop risk-based audit strategies and ensure compliance.

Skills

Good Clinical Practice (GCP)

Good Laboratory Practice (GLP)

Pharmacovigilance (PV)

Leadership

Communication Skills

Root Cause Analysis

Continuous Improvement Techniques

Detail Orientation

Education

BA/BS degree in biological sciences or related field

Tools

eDocument Management

Audit Systems

Training Systems

Job description

Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary:

Spyre Therapeutics is seeking an exceptional candidate to join our Quality team. The 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 year.
• 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.

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.