EDQA - 2018
US ~ Boothwyn, PA
Executive Director, Quality Assurance
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Summary of job purpose
Due to growth and expansion, we have an exciting opportunity for an Executive Director, Quality Assurance to join Quotient Sciences, Philadelphia. As the Executive Director of Quality Assurance, you will be responsible for managing the QA team at Quotient Sciences – Philadelphia and ensuring company’s adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices, global (e.g., FDA, EMA, PMDA) regulatory standards, and internal procedures and practices for all product development, manufacturing, testing and release activities of drug product in support of clinical trials and commercial supply. The Executive Director, QA assures timely completion of internal and supplier audits, hosts client audit, and serves as the point of contact and host for all regulatory inspections. This position also promotes a GMP compliant environment with internal and external stakeholders while ensuring established quality systems are employed.
The successful candidate will have strong leadership skills required to guide change in workplace culture and lead transition and 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. This position will be a member of the senior leadership team and will play a critical role in strategic decision making and directing operations of the organization. The candidate must have:
- B.A. or B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology; fifteen (15) or more years related pharmaceutical products experience; and eight (8) or more years’ experience in a Quality management position in a GMP/pharmaceutical environment or equivalent.
- Strong interpersonal skills with a special focus to customer satisfaction
Other essential skills and experience are:
- Thorough knowledge of GMP principles, solid dosage manufacturing, International Conference on Harmonization (ICH) guidelines, OSHA and DEA regulations
- Able to resolve conflicts internally and with clients
- Thorough knowledge of Quality Risk Management and Data Integrity regulations.
- Demonstrated audit conduct experience is required, including experience supporting regulatory authority inspections.
- Ability to compile and interpret quality metrics.
- Self-directed and able to work effectively across multiple global cultures and with cross functional teams.
- Excellent oral and written communication skills.
- Strong root cause analysis/problem solving, risk assessment and impact analysis abilities.
- Flexible and able to delegate, multi-task and prioritize competing demands/work load.
- Excellent communication, negotiation, conflict management, and cross-functional facilitation skills.
- Experience working in manufacturing and/or laboratory environment
- Successfully completes regulatory and job training requirements
Main tasks and responsibilities
- 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 client audits and regulatory inspections. 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. NDA, ANDA, Annual Product Reports (APRs)). Negotiate and maintain Quality Agreements.
- 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 and commercial supply within established timeframes to meet commitments to clients.
- 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, quality issues, 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 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.
In return you will receive a competitive salary, a generous benefits package, as well as an exciting career within a fast paced and dynamic business.