Director, Quality Control, Commercial Operations
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.
- Provide leadership and support to deliver scientific excellence in compliance with cGMP, continuous improvement as well as ensures internal business targets are met while exceeding customer expectations.
- Provide technical oversight to all areas of quality control and department personnel.
- Comply with and continuously promote adherence to current Good Manufacturing Practices (cGMP) in the QC lab and across the organization.
- Serve as a role model to foster a culture of quality and instill a continuous improvement mindset; ensure the integrity of data and quality of work as a first priority.
Main tasks and responsibilities
- Participate in initial project discussions with potential customers. Work closely with Business Development to provide customer presentations, tours, and preparation of work plans. Prepare/review proposals to support current customers and new business opportunities.
- Serve as a technical subject matter expert for business and encourage sharing of technical knowledge and resources to build and develop talent.
- Assure timely and thorough investigation of laboratory quality events (e.g. OOS, OOT, LIRs, EM excursions, deviations) and appropriate actions to correct issues and prevent their recurrence while maintaining organizational agility.
- Recommend approaches for quality control strategies to facilitate overall project and process success.
- Lead QC activities to support tech transfer from early stage to late stage/commercial operations. Ensure methods transferred are appropriately documented and properly validated. Ensure QC personnel are properly trained on methods/products being transferred. Ensure appropriate and clearly defined specifications.
- Ensure lab resources are scheduled and efficiently utilized to meet targeted and customer expected start times, turnaround times, and quality standards.
- Oversee/approve the procurement, installation, validation and calibration and maintenance of new/existing laboratory instruments, equipment and supplies to ensure reliable, prompt, precise and accurate test data.
- Track, trend and analyze QC data related to products, processes, and environment. Report data to management.
- Lead and direct multiple teams in day-to-day activities and support external customers and commercial projects. Where required, serve as Project Leader for assigned projects and act as a technical liaison with customers to provide written/verbal reports on progress or changes to plan.
- Ensure that procedures and methods required for compliant QC operations remain current with regulatory requirements, compendial standards, and industry expectation.
- Ensure thorough and timely generation, review and approval of test data, protocols, and reports.
- Lead and participate in projects aimed at improving efficiencies, quality and service.
- Drive a culture of continuous improvement focused on compliance, right-first-time and process efficiency while maintaining an environment of open communication.
- Encourage and promote participation and intra/inter-departmental idea sharing in order to build an engaged team. Model Quotient’s behavioral competencies and ensure that the highest level of quality, compliance, and integrity are adhered to in all interactions
- Develop a continuous improvement culture whereby employees are coached and mentored to be change leaders. Managing staffing of team, including ongoing training and professional development and performance management of QC personnel.
- Support the development of long-term strategies to support organizational growth, efficiencies and quality. Establish annual QC department objectives that align with long-term strategies and generate individual objectives for staff that are SMART (Specific, Measurable, Attainable, Realistic, Time-bound) and assure successful achievement of department objectives.
- Assures laboratory runs in a safe, clean, and environmentally sound manner in addition to maintaining detailed records for FDA, DEA, International GMP and Pharmacopeia and safety and environmental purposes.
- Demonstrates sound judgment, goal-oriented actions and work in collaboration with others
- Assures that all work is performed in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA and other international regulatory guidance. Assures group complies with all company and site policies and procedures
- Remains current in profession and industry trends
- Establishes an environment that fosters diversity and encourages teamwork
- Perform other duties as assigned.
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
- Requires B.S. in Chemistry, Pharmacy or equivalent with at least fifteen (15) years of industrial pharmaceutical laboratory hand-on experience, or M.S. or Ph. D. in Chemistry, Pharmacy or equivalent with at least ten (10) years of industrial pharmaceutical laboratory hand-on experience;
- Minimum of at least seven (7) years of industrial pharmaceutical laboratory supervisory experience
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.