Manager/Sr. Manager, Clinical Quality Assurance (CQA)
Mountain View, CA /
Clinical Research & Development – Clinical QA and Safety /
/ Hybrid
About IGM Biosciences, Inc.
IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases, and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists, targeted cytokines, and target neutralizers. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology, and inflammation targets. For more information, please visit www.igmbio.com.
IgM Antibodies and Autoimmune and Inflammatory Diseases
Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases, and IgMs are the first antibody defense against a pathogen infection. We are committed to exploring how the unique structure and binding properties of our IgM platform can improve outcomes for patients with these serious conditions.
IgM Antibodies and Oncology
IGM Biosciences has a T cell engager program, a receptor cross-linking agonist program and a targeted cytokine program in clinical studies for the treatment of patients with solid tumors and hematological malignancies.
Position Summary
We seek a Clinical Quality Assurance (CQA) Manager/Senior Manager to support the company’s Clinical Quality Assurance program. The incumbent will assist in the development and improve the existing Good Clinical Practice (GCP) related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. The incumbent must have an in-depth knowledge of Inspection Readiness/Preparedness practices and procedures. The incumbent is also responsible for assisting in the development of specific internal procedures, training of staff and hosting regulatory inspections. The position involves assisting in global clinical quality operations and acts as a liaison of identified clinical quality related issues with IGM’s functional areas. The candidate will perform audits of vendors, study sites, and internal processes. The candidate will ensure timely completion of goal and program activities according to organizational timeline.
The successful candidate must have the ability to execute CQA tasks in collaboration with cross functional teams; effectively represent QA in a GCP driven team setting and manage quality related activities at clinical vendors, investigator sites and regulatory agencies.
In addition, the candidate must actively collaborate with IGM’s clinical stakeholders and act as a catalyst for continuous process improvement.
Responsibilities:
· Establish and maintain strong business relationships with both senior and operating level business leaders
· Assist with the development and maintenance of GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policy.
· Assist with cross functional Inspection Readiness/Preparedness activities
· Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
Assist with creation/management/maintenance of quality plans for the CQA department.
· Collaborate with staff performing quality audits of investigator sites and various clinical vendors.
· Provide CQA input for quality reviews of clinical study documents, including, but not limited to investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms etc.
· Assist and collaborate with staff performing internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines.
· Provide expert CQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
· Support the administration of the company’s training program by overseeing the conduct of GCP training to internal departments and externally, as applicable.
· Report GCP related deficiencies to senior management as well as plans for corrective and/or preventive actions (CAPA).
· Assist clinical study teams in the development of CAPAs.
· Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
· Coordinate responses to regulatory agency inspections.
· Assist with review regulatory submissions for clarity and compliance to current regulations
Qualifications:
· Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
· Excellent verbal and written communication skills, ability to collaborate with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
· Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
· Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
· Ability to deal with ambiguity, creative and pragmatic approach to problem solving
· Travel may be required between 15 and 20% of the time
· Auditor certifications a plus
B.S./M.S. in a relevant science field
8+ years of progressive global quality / regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
The typical annual salary range for this full-time position is $118,000 - $168,000, plus eligibility for cash and equity incentives.
This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
We offer a fast-paced, collaborative, team-based, and family-like work environment.
One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
· Medical, dental and vision insurance.
· The full premium amount for our employees and their dependents is covered by IGM
· FSA (Flexible Spending Account)
· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
· 401(k) Plan
· 120 hours of Paid Time Off, 5 sick days per year, 11 holidays
· Cell phone & internet subsidy
· Employee Referral Bonus Program
· Annual training budget for professional development
· Commuter Benefit
· Annual bonus program
· New hire stock options
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
