Director, Quality Assurance - Clinical

Job Title:Director, Quality Assurance - Clinical
Reference:QA - 2021
Location US ~ Garnet Valley, PA
Type: Full Time

Company Overview

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 1,100 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.


The Role

  • Responsible for the oversight of the Clinical Quality Assurance department at Quotient Sciences for all product development, manufacturing, testing and release activities of drug product in support of Phase I & II clinical trials.
  • Ensure company adherence to GxPs including Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), applicable regulatory standards, and internal procedures and practices.
  • Assures timely completion of internal and supplier audits, customer audits, and serves as the point of contact and host for all regulatory inspections.  Promotes a GMP compliant environment with internal and external stakeholders while ensuring established quality systems are employed
  • To comply & adhere to GXP guidelines and regulations as required of this role.
  • Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.  To comply & adhere to Good Manufacturing Practice (GMP) standards.

Main tasks and responsibilities will include:

  • Assure successful outcomes of client audits and regulatory inspections by managing the sites compliance status, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective cGMP Quality Management System.  Serve as audit host for regulatory inspections and ensure that customer audits are scheduled and hosted effectively.  As required, lead the resolution of and response to any audit/inspection findings.  Effectively communicate audit and inspection outcomes to site and Executive Management.
  • Assure that client projects are properly staffed with knowledgeable QA resources who serve as engaged and responsible project team members that contribute to the timely execution of projects, the customer’s satisfaction, and assure regulatory requirements are fulfilled. 
  • Provide QA oversight and review of regulatory documents in support of client filings (i.e. INDs & CTAs).  Review and approve Quality Agreements with customers and suppliers.
  • Ensure QA oversight and review and approval of master and executed batch records, CoAs, and analytical test results. Oversee lot disposition and release activities for drug products in support of clinical trials within established timeframes to meet commitments to customers.
  • Track and trend quality metrics analyze trends and identify and assure implementation of improvement initiatives. Assure site metrics are reported to site and global management.
  • Plan, direct and, as necessary, conduct internal compliance audits to assure compliance to company policies and procedures.  Collaborate with department leaders to identify effective corrective actions that meet regulatory requirements while maintaining organizational agility.  
  • Plan, direct and, as necessary, conduct external compliance audits of vendors.  Assure timely resolution of any identified non-compliances to minimize risk to quality and supply of products and/or services.
  • Identify, communicate, and escalate quality and compliance risks.  Provide direction for and assure appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency.
  • Perform detailed review of policies, procedures, work instructions to assure compliance to standards and efficient and effective practices.  Assure the control of documents is maintained so only current, approved versions are accessible to personnel; assure periodic review of procedures and work instructions; assure quality records are appropriately archived.  Serve as a champion for the effective use of the QMS (training, procedures, deviations, CAPA) across the site.
  • Maintain ownership for the Site Master File and Site Master Validation Plan. 
  • Assure timely issuance, resolution and closure of quality issues and CAPAs in response to supplier, manufacturing and/or laboratory discrepancies.  Provide QA leadership to assure thorough root cause investigations and effective corrective actions to prevent recurrences. 
  • Continuously remain up to date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on GMP quality and compliance related issues.
  • Establish annual clinical QA department objectives that align with site objectives and global QA objectives.  Generate individual objectives that are SMART (Specific, Measurable, Attainable, Realistic, Time-bound) for staff that assure successful achievement of department objectives. 
  • Facilitate an environment that allows employees to succeed in their roles.  Coach and develop staff and encourage continued professional development.  Conduct communication and feedback sessions through team meetings and one-on-one interactions to assure staff receives appropriate direction, feedback and coaching for success. 
  • Develop productive, dynamic, professional working relationships with site personnel and colleagues in other global Quality Assurance functions.  Provide full and timely QA support to internal and external customers.
  • Perform other duties as assigned.

Additional Task/Responsibilities

  • Line management responsibility for approximately 3- 5 direct reports in the clinical Quality Assurance department


Job Demands

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


The Candidate

  • Bachelor’s Degree in a scientific field, e.g., chemistry, biology, or pharmacology; ten (10) or more years related pharmaceutical products experience; and five (5) or more years’ experience in a Quality management position in a GMP/pharmaceutical environment or equivalent.
  • Strong leadership skills required to drive a culture of delivery and excellence through continuous improvement; a hands-on, participative manager who will lead by example and develop an internal team.
  • Strong interpersonal skills with a special focus on communication, collaboration and customer satisfaction.


Company benefits

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.