Manager, GCP QA
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Represent Quotient Sciences QA on projects support to sponsors for phase 1 clinical trial design and execution.
- Ensure efficient and effective implementation of regulatory requirements into the quality management system, proactively communicate compliance requirements to the site teams, and serve as a role model for the behaviors necessary to maintain compliant GCP/GxP practices and advance the quality culture.
- Supporting the provision and development of efficient and effective Quality Assurance (QA) systems for clinical and scientific research studies
- To comply & adhere to GCP/GxP guidelines and regulations as required of this role.
Main tasks and responsibilities
- Ensure efficient and effective execution of QA systems in accordance with procedures, policies, work instructions, and regulatory requirements.
- Help develop key quality indicators and analyze data and facts to identify and solve problems and prevent future problems from occurring.
- Support the collection and analysis of quality metrics and lead initiatives to improve performance to target.
- Serve as a QA resource to provide input and guidance to cross-function teams on quality issues, Conduct peer review of documentation, as necessary.
- Serve as the QA representative to customers, regulators and project teams for early phase support of clinical trials. Actively participate in project meetings.
- Perform audits to monitor compliance of internal operations with internal procedures and regulatory requirements (GCP), including:
- Documentation such as clinical protocols and reports
- Facility audits
- Process audits/ inspections
- Provide guidance on corrective and preventive actions to address audit findings.
- Perform vendor audits and assessments covering a wide range of suppliers and subcontractors that provide clinical laboratory testing services, clinical trial material, IT services, and other GCP-related products and services.
- Develop, implement, and maintain the site’s quality system. Author, review and approve SOPs and assure compliance with current regulatory requirements. Assure documents are issued, controlled, and archived in accordance with company procedures.
- Participate in the change control process to ensure changes to processes, systems, equipment, and facilities are appropriately assessed and implemented after proper verification of changes.
- Interpret and provide guidance, coaching, and mentoring to other functions and, where necessary customers on regulatory requirements and expectations.
- Participate in the planning and execution of customer audits related to clinical projects. Maintain accountability to ensure responses to customer audit findings for clinical projects are complete and timely.
- Participate in investigations of quality issues. Assure that root cause(s) are identified and effective corrective actions are implemented in a timely manner to mitigate the recurrence of issues.
- Participate in regulatory inspections to ensure successful results. Conduct For-Cause investigations.
- Develop productive, dynamic, professional working relationships founded on trust and respect with project team personnel and customers.
- Coach and mentor other QA clinical personnel and assure alignment and consistent decision-making within the team.
- Provide GCP training and other training as required for new and existing employees.
- Perform other duties as required.
- Bachelor’s Degree in a scientific field B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology.
- Minimum 6 years of relevant experience in life sciences quality or relevant experience in a regulated field
- Strong subject matter expertise in quality management systems, GCP requirements, ICH E6, ICH E8, 21 CFR Part 11, Annex 11, Data Integrity, Risk Approach and Quality by Design (QbD)
- Solid understanding of Phase I Clinical Trials, and strong knowledge of the complete regulatory framework around clinical trials
- Experience in conducting internal audits against company procedures and regulatory requirements, hosting customer audits, and knowledge of supplier management.
- Excellent written and oral communication skills
- Self-directed and strong ability to work effectively across multiple cultures and with cross-functional teams
- Strong interpersonal skills with a special focus on customer satisfaction.
- Work independently with minimal supervision with the ability to multi-task, work in a fast-paced environment and prioritize work to assure business and compliance objectives are met
- Detail oriented with excellent problem-solving and organizational skills.
- Effective persuasion and influence skills
- and mentoring on quality and compliance
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
In return you will receive a competitive salary, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.