Senior Manager / Director Quality Assurance - Anywhere, UK
Office-based or Remote
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
This role is a key position within Synteract’s Quality Assurance Group. The person appointed will report to the Executive Director of Quality Assurance and will be responsible for leading the QA Audit Defense Team. This is an opportunity to be part of a restructured and re-focused QA Group with an emphasis on adding value to the Company.
The ideal candidate will have proven leadership capabilities in a senior quality assurance role, be pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy. Must also be an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives. Job level will be based upon experience.
Specific tasks would include:
- Provide strong leadership of the QA Audit Defense Team demonstrating maturity, integrity experience and knowledge of subject area.
- Act as expert on broad based routine GCP and regulatory compliance issues and provide leadership to teams in areas of regulatory compliance.
- Provide solutions for extremely complex and unique GCP problems to balance compliance and business needs
- Provide leadership and manage the global related day to day activities of the Quality Assurance Audit Defense team to host Sponsor audits and Regulatory inspections, manage audit observations, quality issues CAPAs, follow-up and effectiveness checks.
- Works with internal customers to ensure that inspection findings are clearly communicated and understood. Evaluate inspection-finding responses to ensure they are written to address the findings appropriately
- Interact with Health Authority Inspectors to represent the company when needed.
- Provide interpretation of external requirements and develop practical solution to attain full compliance. Interact independently with staff members of other functional groups and senior management to resolve issues.
- Collaborate with operational teams to ensure continuous inspection readiness.
- Lead the QA review of potential Serious Breach and suspected Scientific Misconduct cases.
- Collaborate with the Quality Assurance Auditing team lead and provide input to the global audit program based on findings, quality issues and trending.
- Perform review of quality metrics, CAPA findings and business process improvement opportunities, recommending effective solutions to enhance quality and efficiency
- Participate in establishing, maintaining and updating standards and ensuring compliance of standards with applicable regulatory requirements
- Monitor and reinforce timely completion of corrective and preventive actions that are defined to address GCP issues, regardless of the source.
- Escalate critical quality problems to Executive Director Quality Assurance in a timely manner.
- Perform and/or coordinates detailed review of QA policies, procedures and work instructions.
- Oversee company-wide required annual GCP training.
- Participate in and guide QA process improvement.
- Participate in and guide process improvement activities across the organization as assigned.
- Bachelor of Science/Arts (BS/BA) degree, preferred in a science related field.
- Minimum of 8 (eight) years’ experience in the pharmaceutical/CRO industries, with at least 4 (four) years in Clinical Quality Assurance, preferably within a GCP environment.
- Recognized expertise in quality assurance practices and mastery of GCP regulatory compliance requirements.
- Excellent technical knowledge, understanding and experience in applying ICH Good Clinical Practices.
- Experience in conducting GCP, compliance and process audits;
- Experience in conducting all audit areas, Investigator Sites, Vendors, Data Management, Biostatistics, Safety Management, Trial Master File etc.
- Experience hosting Regulatory Authority inspections and Sponsor audits and interacting with sponsor/client representatives;
- Independent thinking and planning ability;
- Must be able to manage all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
- Must be able to prioritize work effectively to meet timelines.
- Excellent written and verbal communication skills; must be able to professionally, clearly, concisely and consistently communicate to externa and internal customers.
- Exceptional teamwork skills
- Ability to travel, requires approximately 25% travel
If you’re passionate about bringing clinical trials to life, we encourage you to apply today!
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.