Quality Assurance Leader
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.
This Quality Assurance Leader is responsible for leading a team of QA professionals providing support to customers from early clinical phases through commercialization- and oversee product development, manufacturing, testing and release activities of drug product in support of clinical (all phases) and commercial supplies. The Associate Director is also responsible for ensuring company adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices, global (e.g., FDA, EMA and DEA) regulatory standards, and internal procedures and practices. The Associate Director will support the site leadership team to ensure efficient and effective implementation of regulatory requirements into the quality management system, proactively communicate compliance requirements to the project teams, and serve as a role model for the behaviors necessary to maintain compliant GxP practices and advance the quality culture.
Main tasks and responsibilities will include:
- Develop productive, dynamic, professional working relationships founded in trust and respect with staff, project team personnel and customers.
- Serve as a champion for a right first-time culture by reviewing and challenging existing processes and driving process improvements.
- Perform as a hands-on leader and develop the QA team. Coach and mentor staff to develop their professional skills and competencies and assure alignment and consistent decision making within the team.
- Coordinate team activities to ensure timely, thorough and accurate execution of tasks to support the business. Report on the team’s performance to management.
- As a member of the QA leadership team, play a critical role in tactical decision making.
- Selecting, developing, and evaluating personnel to ensure that the efficient operation of the function is fulfilled.
- Ensure adequate QA engagement with project teams for early phase pharmaceutical formulation, development and manufacturing in support of Clinical & Commercial distribution. Actively participate in project meetings.
- Ensure all quality deliverables required for the success of the project are satisfactorily completed on time. Coordinate timely review, feedback and approval of project and product related documentation including, but not limited to, master batch records, pharmaceutical reports, equipment, test method and process qualification/verification protocols and reports, stability study documents, risk assessments, product specifications, and SOPs. Lead negotiation and assure execution of Quality Agreements with customers. Assure suppliers and subcontractors to be used for the product are properly qualified in accordance with the supplier management program.
- Ensure quality strategy for clinical and commercial projects are clearly understood across the project team and with the customer. As required, present data and complex messages clearly and confidently across multiple levels of the organization.
- Ensure timely review and release of materials and components to be used in the manufacture of clinical and commercial products.
- Ensure thorough and timely review executed batch records, analytical test results and raw data, and release product after ensuring all requirements have been fulfilled and product conforms to specifications.
- Anticipate potential areas of issue/risk and proactively identify and implement solutions to prevent occurrence.
- Participate in and guide staff on investigations related to quality events (e.g. deviations, customer complaints, out-of-specifications or atypical results). Provide guidance for timely and thorough issue resolution including CAPAs to minimize potential for issue recurrence, acting always with an appropriate sense of urgency. Review and approve investigation reports.
- For products moving from late stage, participate in tech transfer activities to support customer registration, scale up, validation and commercialization readiness.
- Interpret and provide guidance, coaching and mentoring to staff, peers, and, where necessary, customers on regulatory requirements and expectations.
- Ensure procedures that govern the formulation, development and manufacturing of clinical and commercial products are current to regulatory requirements, industry standards and best practices, and support efficient execution of work.
- Participate in the planning and execution of customer audits related to projects. Maintain accountability to ensure responses to customer audit findings for projects are complete and timely.
- Ensure the team is inspection ready at all times. Participate in regulatory inspections to ensure successful results.
- Perform other duties as assigned.
- While performing the duties of this job, the employee is frequently required to stand and walk
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl.
- The employee must occasionally lift and/or move up to 10 pounds.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Must be able to qualify for respiratory protective equipment use.
- B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology;
- Minimum eight (8) years’ related experience in QA/QC in manufacturing or CMC function in a GMP/pharmaceutical environment or equivalent.
- Advanced degree or Certification(s), such as those offered by AQS, preferred.
- Strong managerial and supervisory skills to guide change in the workplace culture, drive continuous improvement and manage performance of small teams to deliver results
- Strong subject matter expertise of pharmaceutical quality systems, CGMP requirements, CMC requirements, 21 CFR Part 11, Data Integrity, and Quality by Design (QbD).
- Experience in solid dose manufacturing desirable.
- 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.
- Effective persuasion and influence skills
- Ability to multi-task and work in a fast-paced environment.
In return, you will receive a competitive salary, a generous benefits package, 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.