Associate Director, Quality Assurance (GCP/Clinical)

Position Summary

Ensures and supports the development of GCP quality systems and processes in compliance with applicable regulations. Supports the development of department quality systems, provides quality oversight at the CROs and investigator sites, perform and support GCP audits, as appropriate.

Essential Functions

• Provides quality oversight of CROs, CSPs, clinical monitors and investigator sites activities.
• Ensures regulatory compliance to the clinical study, clinical trial material, and clinical system.
• Monitors and assesses compliance issues identified across clinical programs.
• Provides appropriate risk analysis of systemic issues with appropriate solutions.
• Facilitates investigations of GCP related activities.
• Works with cross-functional internal and external teams in developing applicable processes and systems and identifies and mitigates GCP quality and compliance issues.
• Develops and updates SOPs related to GCP activities and regulatory compliance.
• Implements process improvements to ensure GCP compliance.
• Compiles and reports quality/KPI metric data to support GCP activities and management review.
• Participates in the evaluation and selection of CROs and CSPs.
• Conducts audits of clinical study, including CSR, TMF, and safety reports.
• Supports internal audit program and regulatory authority inspections.
• Reviews Informed Consent Forms, Pharmacy Manuals and Investigator Brochures, etc. for compliance.
• Performs other duties, as assigned.

Knowledge and Competencies

• Strong working knowledge of GCP regulations and ICH guidelines.
• Conducting GCP audits of clinical studies, CROs and investigator sites.
• Ability to work and make decisions independently and as part of a team.
• Experience in supporting inspection readiness activities.
• Strong and effective verbal, interpersonal, and written communication skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Strong collaboration, strategic thinking, leadership, and teamwork skills.
• Advanced computer skills. (Experience with eTMF and other eQMS and document control systems preferred.).
• Ability to travel up to 25%, domestically and internationally. Due to COVID, travel is currently restricted but will resume according to public health mandates.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The noise level in the work environment is usually moderate.
• May be required to travel by plane or car.

This position requires working with biological and/or chemical hazards.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Requirements

Qualifications

Education & Experience

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, Nursing, Pharmacy, etc.).
• Minimum, 10 years of relevant bio-pharmaceutical industry experience, with a minimum 8 years of Quality Assurance and at least 6 years GCP compliance.