Director/Senior Director, Head of Global Quality Management System
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 help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,300 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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
We have an exciting career opportunity for a Director/Senior Director, Head of Global Quality Management System based at our site in Nottingham.
Reporting to the Senior Vice President, Global Quality and Regulatory, the Director, Global Quality Management System will be responsible for the establishment of the strategic direction and continued harmonization of the company’s Quality Management System (QMS) and applications in support of our phase appropriate design lifecycle management.
This role will assure the continued compliance of the company’s QMS with applicable global regulations and standards, and monitor metrics to routinely assess the compliance profile at each site. Additionally, this role will drive continuous improvement programs to advance GxP execution and the quality culture across Quotient Sciences network.
This position will manage the following core functions:
- Global Supplier/Vendor Audits and Qualification – auditor qualification
- Global Systems Compliance in partnership with IT
- Validation (vertically integrated with site-based teams)
- CSV/ Data Integrity (vertically integrated with site-based teams)
- eQMS/eDMS (Veeva) (vertically integrated with site-based teams)
Main tasks and responsibilities
- Establish strategic direction, harmonization, life-cycle management and continuous improvement of Policies, Standard Operating Procedures, Work Instructions, Templates, and other required documents to assure continued efficient, effective and compliant quality management system that supports the company’s business.
- Collaborate with site Quality and Regulatory Affairs team across the organization and other key stakeholders to identify local quality processes that can be harmonized across all sites while integrating industry best-practices.
- Maintain up to date knowledge of GxP regulations, guidelines and expectations of regulatory agencies around the world for markets in which we operate or plan to operate. Monitor global regulations and standards for changes that impact the Quotient QMS.
- Communicate changes to site Quality and Regulatory Affairs team and proactively work to assure global policies and procedures remain compliant.
- Effectively communicate across the business to keep all functions informed on new or changing quality system requirements affecting their area. Influence others to ensure compliance with company policies and procedures through positive interactions and gain alignment and support for improvement activities.
- Oversee the implementation and maintenance of the company’s global Quality applications (e.g. electronic document management system, electronic quality management system) to assure consistent practices across all sites. Identify opportunities to maximize system functionality to drive efficiency enhancements. Oversee functions that serve as the system administrators.
- Maintain the global quality metrics dashboard, ensure metrics are accurately and consistently reported in a timely manner, and track/trend metrics across sites to monitor the company’s compliance profile and assure the effectiveness of the global quality systems. Collaborate with site Quality and Regulatory Affairs team to identify and implement effective and sustainable corrective actions, when needed, to address adverse trends in metrics. Issue and present trend reports and quality improvement efforts to global and site management.
- Establish, implement and maintain programs to ensure audit readiness at all Quotient Sciences’ sites to achieve successful audit outcomes.
- Support quality audits and inspections at all sites. Assess any audit observations issued to a single Quotient site to identify similar risks at other sites and lead activities to mitigate and avoid similar audit findings across sites.
- Collaborate with site Quality and Regulatory Affairs team leaders on responses to any regulatory audit findings to assure that the response is comprehensive, timely, and will satisfy the expectations of the regulatory authority.
- Establish and maintain auditor qualification programs to assure required personnel maintain the skills and competencies necessary to effectively conduct internal and supplier audits.
- Collaborate with site Quality and Regulatory Affairs team to establish annual schedules for internal audits that follow risk-based approaches to assess all elements of the quality management system. Participate in one audit per year at each site to assess the site’s Quality team.
- Provide oversight of site investigations of critical quality issues and customer audit findings to assure thorough root cause investigation, comprehensive and accurate risk assessment and timely, effective and sustainable corrective actions.
- Establish and maintain the company’s training and role-based qualification program. Establish standard criteria and minimum requirements for on-the-job training and associated performance assessments. Establish a Train-the-Trainer program to assure that required personnel maintain the skills and competencies necessary to effectively execute training within each site. As necessary, develop quality system training material for site Quality and Regulatory Affairs team to execute locally.
- Serve as a Quality System point of contact for all sites and provide guidance and expertise in the effective and compliant execution of the QMS at each site. As required, prepare and deliver GxP training to ensure personnel maintain the required competency and thorough understanding of effective and compliant QMS execution.
- Identify compliance gaps and adverse trends in quality systems and escalate events requiring immediate action to management. Lead global teams to resolve compliance issues.
- Manage direct reports, drive a high performing organization, and develop personnel for current and future roles within Quotient Sciences.
- Perform other duties as assigned.
- Travel expectations - 10%
- People Management - 4 direct reports and 5 indirect
Qualifications and experience required for competent performance
The successful candidate will have strong leadership skills required to guide change in workplace culture and participate in integration activities taking place throughout our global organization. The candidate must be a hands-on, participative manager who will lead by example and develop an internal team. The candidate must have:
- Batchelor’s degree in a related discipline with extensive experience related pharmaceutical products experience;
- Considerable experience in a Quality management position in pharmaceutical operations;
- In depth knowledge and operational experience of the pharmaceutical lifecycle management of two or more GxP areas (e.g., GMP, GDP, GCP, GLP, GvP);
- Strong interpersonal skills and the ability to build and maintain effective collaboration with key internal and external stakeholders;
- Ability to effectively communicate at all levels of the organization so that others fully understand the requirements of the company’s QMS.
Other essential skills and experience are:
- In-depth knowledge of international regulatory requirements (FDA, EMA, MHRA, ICH, PIC/S) and Risk Management principles with the ability to interpret and apply requirements[EW3] ;
- Experience in dealing with regulatory authorities;
- Demonstrated ability to compile and interpret quality metrics and lead teams to improved performance demonstrated through metrics;
- Strong root cause analysis, problem solving, risk assessment and impact analysis;
- Excellent oral and written communication skills, and technical writing capabilities;
- Self-directed and able to work effectively across multiple global cultures and with cross functional teams;
- Successfully completes regulatory and job training requirements.
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, 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, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. 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 are welcome.