Department: Quality Assurance
Education Required: Bachelor’s degree, preferably in Science
The Manager of GCP Quality Assurance is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance. This position will be primarily responsible for ensuring research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.
Essential Functions of the job:
Manage and oversee the GCP Quality Assurance activities:
- Perform quality assurance (QA) activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development
- Develop/improve and manage quality systems and processes to include:
- Creation/revision of appropriate SOPs
- Maintaining key QA systems, such as; investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits, developing and managing integrated Quality Management Risk plans.
- Supporting the activities related to the vendor management process training, SOPs, etc.
- Conducting/managing routine and for cause audit of investigator site, vendors, internal audits, etc.
- Conducting/managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc.
- Performing the review of trends and reporting significant investigation/deviation issues and system deficiencies to senior management, as appropriate
- Lead and manage GCP Quality investigations
- Participate and represent Clinical Quality in meetings and discussions as needed
- Perform inspection readiness activities and participate in managing regulatory health authority inspections.
- Promote continuous improvement
- Expert knowledge of GCP, particularly FDA and ICH requirement
- Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
- Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
- Strong leadership experience and mentoring skills
- Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations
- Other duties as assigned
This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required. Therefore, it is required to have strong leadership experience and mentoring skills.
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
- PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
- At least 3 years of QA experience in a GCP setting for all phases of clinical trials.
- Experience auditing GCP vendors who provide clinical trial and non-clinical study services, internal GCP processes and documents, and clinical investigator sites.
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
- Quality Assurance
- Clinical Operations
- Clinical Business Operations
- Medical Monitors
- Regulatory Affairs
- Interacts with all levels of BeiGene
May require travel, up to 20%