Director, Clinical Supply, CMC QA
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
The Role:
Reporting to the VP, CMC and Distribution QA, this position is responsible for designing and implementing an effective, robust quality assurance system for support of the Clinical supply chain through partnerships internally and externally. This position will identify and evaluate compliance risks and contribute to the development of streamlined and efficient GXP procedures and processes as they relate to Immunovant clinical supply chain.
This position will collaborate cross functionally to ensure compliant release and distribution of investigational products for multiple global clinical studies/programs leading to product approvals.
Key Responsibilities:
- Drive continuous improvement and ensure effective implementation and maintenance of systems at Immunovant in compliance with regulations and guidelines including:
o Notification to Management
o IRT post-release issue resolution
o Unblinding event investigation
o Expiry extension re-labeling.
o Product stock recovery (clinical recalls) - Serve as a quality point of contact and contributor in authoring and revising technical documentation including but not limited to: Standard Operating Procedures, Pharmacy Manuals, Risk Assessments,, Quality Agreements templates and tracking, IRT Systems Configuration and IRT Use Requirements Specifications;
- Work closely with CMC & Clinical Operations functions to build/improve appropriate controls and apply best practices to monitor investigational product post-release through handling at clinical trial sites, including evaluation of temperature excursions, product complaints and support Just In Time labeling for study start up and resupply;
- Partner cross-functionally to establish regulatory surveillance that results in appropriate timely compliance actions.
- Partner cross-functionally to establish Inspection Readiness and Management processes and procedures.
- Partner with the Sr. Director of Audit to drive actions resulting from internal and external audits,
Requirements:
- BS/BA degree in a scientific or allied health field; advanced degree preferred with a minimum of 8+ years of hands-on experience in in the pharmaceutical industry;
- Self-motivated nimble leader with extensive knowledge of cGMP/GCP regulations and requirements (ICH GCPs, EU GMPs, 21 CFR 211/600) and applicable global regulations for drug development;
- Hands on expertise and advanced knowledge in the conduct and resolution of complex quality issues, root cause analysis, and the translation of findings into corrective action plans that mitigate risks to product quality, study subjects, data integrity, and study outcome;
- Strong technical knowledge included but not limited to: vendor management, risk management, auditing techniques and quality governance;
- Solid quality culture knowledge and understanding how to influence and improve overall compliance.
Work Environment:
- Remote-based
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel are required (10-20%)
Salary range for posting
$200,000 - $215,000 USD
Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.
Apply for this job
*
indicates a required field