Director, Clinical Quality Assurance (GCP)

Corbus Pharmaceuticals Inc•Norwood, MA

2d•Hybrid

About The Position

The Director, Clinical Quality Assurance, reporting directly to the Senior Director, Head of Quality, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Corbus sponsored clinical trials (Early-Late Phase) with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Corbus Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following clinical QA areas: Vendor Quality, QA audit program, Corbus quality systems, and internal/clinical study team support. The Director, Clinical QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness with regards to all quality requirements, and regulatory standards while supporting continuous clinical supply and delivery expectations. The ideal candidate will be based in the Boston area with 3 days in office in Norwood, MA.

Requirements

12+ years relevant work experience within the GxP (GCP heavy) Biotechnology/Pharmaceutical industry.
Scientific or engineering degree (BSc, MSc, PhD), Min Bachelor of Science Degree in Biology, Biomedical Engineering, Engineering, or equivalent
Knowledge of Good Clinical Practice (GCP) FDA, MHRA and EMA regulatory requirements applicable to Biologics therapy products.
Very good scientific and medical/clinical expertise.
Solid expertise in GCP and ICH clinical requirements, clinical development and methodologies of clinical studies.
Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels
Well organized and detail-oriented; must be able to effectively prioritize work
Eager to learn, interact cooperatively and effectively with others in a team environment
Possess advanced word processing, data entry and data presentation computer skills
Ability to influence and work effectively with business partners across regions and cultures
Displays organizational leadership qualities and effective coaching abilities.
Listening, interpreting, and summarizing information skills must be highly developed.
Ability to work both independently with direction and within project teams to attain goals.
Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
Strong organizational skills and the ability to participate effectively cross-functionally.
Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.
Fluency in written and spoken English. Fluency in Chinese is a plus.
Demonstrated ability to lead on-site corporate, external, or Health Authority inspections
A self-starter and a team player who thrives in a fast-paced dynamic team environment.
Proficiency in using Veeva Clinical and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint). Veeva Quality is a plus.
Willingness to travel to various meetings/audits, may include overnight trips. Some international travel may be required.
May require approximately 10-25% travel

Nice To Haves

Preferred experience in providing oversight and supporting GLP related studies
Certification as an auditor by an organization recognized is desirable within the pharmaceutical industry.
Fluency in Chinese is a plus.
Veeva Quality is a plus.

Responsibilities

Work collaboratively with the internal Corbus Clinical Operations Team to ensure compliance standards are achieved.
Manage the GCP Quality interface and support for all Clinical Project Teams.
Identify and access compliance risk and develop and implement risk mitigation measures.
Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.
Review and approve Clinical SOPs.
Develop and Implement Clinical QA SOPs.
Develop and implement detailed audit plans and yearly GCP audit schedules.
Ensure the timely and effective follow up of all identified or assigned quality issues.
Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.
Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.
Direct and/or deliver yearly GCP training for internal staff as needed.
Work closely with Clinical Development, Clinical Operations, and other clinical functions/departments to ensure compliance readiness.
Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies.
Provide management reports on audit strategy, plans, and findings
Support process improvement initiatives; lead continuous improvements within Quality.
Maintain knowledge of GCP regulations, guidelines, company standards and procedures.
Preferred experience in providing oversight and supporting GLP related studies