Director/Sr. Director GCP Quality

Location Boston, Suffolk, Massachusetts
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Caroline Webster

Contact email:
Contact phone: 16179821238
Published: about 1 month ago
Expiry date: 30 July 2021

Type: Full time, permanent

Location: Boston, MA or remote (US)

The company:

We have partnered with a small biotech sponsor company with an exciting drug development platform, dedicated to the development and commercialization of novel therapeutics to treat serious viral diseases across multiple therapeutic areas including hematologic and musculoskeletal disorders. Join a fantastic team of industry leaders as this company in a fast-growing company.

The role:

This individual will partner with Clinical Operations, Regulatory, and other internal and external functions to establish risk based GCP processes and procedures, ensure compliance with applicable regulations with regards to sponsor oversight of global clinical programs. The role will be a key member of the quality team that will assist in development of a phase appropriate GCP quality system for early phase clinical trials, and further develop the Clinical QA function to ensure Inspection Readiness as it relates to clinical trials and commercialization. This position will work closely with key stakeholders including Clinical Development Operations, Regulatory Affairs, and Project Management. Primary responsibilities include:

  • Collaborate with manager and stakeholders to define GCP QA strategy and capability to support clinical programs while maintaining a strong independent role for QA decision-making.

  • Develop appropriate procedures and documentation to ensure standards, practices and policies and procedures are in compliance with applicable regulations.

  • Conduct QA reviews of project-related Clinical Development essential documents (e.g., protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports)

  • Manage GCP training program.

  • Manage qualification of clinical vendors including CROs, laboratories, and other service providers. Coordinate domestic and international audits of clinical vendors. Ensure audit reports and corrective actions are developed and completed within mandated timelines

  • Collaborate with Clinical Development Operations to develop and execute or oversee audit plans for study investigator sites.

  • Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks as needed; facilitate identification of root cause and develop appropriate CAPAs; ensure reporting of confirmed violation to regulatory authorities are on time.

  • Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness.

  • Establish and maintain Clinical Quality metrics with clinical vendors. Assess and escalate critical and major quality events to management.

  • Support the development of the Quality Management System framework for Clinical Development; provide input for improvement of QA processes.

  • Provide GCP oversight including but not limited to deviations, corrective and preventative actions, investigations, and change controls, as applicable.

  • Support regulatory filing and related correspondence from global regulatory authorities.

  • Maintain effective working relationships with internal and external cross-functional teams.

Education and Skills Requirements:

  • Bachelor’s degree in a scientific discipline is required.

  • 8+ years of applicable experiences in a GCP Quality with biopharmaceutical industry.

  • Broad understanding of international regulations and guidance documents, FDA & EMA regulations and ICH Guidelines for clinical development

  • In-depth knowledge of clinical trial process workflow from conception to study close-out; understanding of source clinical documentation and TMF

  • Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA.

  • Must have experience conducting GCP Vendor Audits

  • A proven track record of demonstrating good judgement & decision-making experience.

  • Excellent organizational skills

  • Ability to concisely present quality events and the criticality to internal stakeholders

  • Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues.

  • Ability to work effectively on multiple projects simultaneously with minimum supervision.

  • Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches or solutions.


Our client is deeply committed to workplace diversity and inclusion and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

Salary: On application