DQCO - 2019
US ~ Boothwyn, PA
Director, QA Commercial Operations
Our growing and successful business comprises of over 800 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, specialising 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.
The Director of Quality Assurance, Commercial Operations is responsible for:
- Managing the Quality Assurance team and ensuring company adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices, global (e.g., FDA, EMA, and PMDA) regulatory standards, and internal procedures and practices for manufacturing, testing and release activities of drug product in support of registration batch manufacturing, validation activities and commercial supply.
- Hosting and assuring timely resolution of any observations resulting from internal audits, customer audits, and regulatory inspections.
- Collaborating cross-functionally to build relationships, meet customer expectations, and ensure product is manufactured right the first time.
- Driving continuous quality improvement programs and fostering the quality culture across Quotient Sciences.
Main tasks and responsibilities will include:
- Directly lead, manage and monitor the routine activities of the QA commercial operations team and 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. Operate within appropriate budgetary constraints.
- Assure successful outcomes of customer audits and regulatory inspections by managing quality and compliance activities related to commercial operations, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective cGMP Quality Management System. Serve as an 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.
- Provide QA review of regulatory documents in support of customer filings (i.e. NDA, ANDA). Oversee data gathering, analysis and reporting of manufacturing data for Annual Product Reports (APRs) in support of customer filings. Negotiate and maintain Quality Agreements.
- Assure effective systems, processes, validations, and controls are established and maintained to transition new products and technologies from a development to commercial operations environment. Oversee implementation of ongoing verification activities to assure products are continuously manufactured right the first time.
- Assure timely issuance, resolution and closure of investigations (e.g. deviations, customer complaints), 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. Collaborate with department leaders to identify effective corrective actions that meet regulatory requirements while maintaining organizational agility.
- Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.
- Interact and develop relationships with customers and continuously improve all aspects of quality to achieve and sustain conformance to internal and external requirements.
- Ensure QA review and approval of master and executed batch records, CoAs, and analytical test results. Ensure effective and reliable lot disposition and release activities for drug products within established timeframes to meet customer commitments.
- Track and trend quality metrics, analyze trends and identify and assure implementation of improvement initiatives. Assure functional metrics are reported to management.
- Ensure quality system processes and procedures in support of commercial operations consistently align with current regulatory requirements, industry best practices, and support efficient and effective execution.
- Participate in the creation of annual QA department objectives that align with site objectives and global QA objectives. Generate individual objectives for staff that are SMART (Specific, Measurable, Attainable, Realistic, Time-bound) and assure successful achievement of department objectives.
- 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.
The job may involve the following:
- Working to 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.
- 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 ten (10) years’ related pharmaceutical manufacturing experience; and five (5) or more years’ experience in a Quality management position in a GMP/pharmaceutical environment or equivalent.
- Strong working knowledge of pharmaceutical quality systems
- Strong leadership skills to guide change in workplace culture and lead organizational transformation
- Demonstrated success in coaching, mentoring and training across functions
- Excellent written and oral communication skills
- Ability to manage performance of a department and deliver results
- Ability to think and act strategically
- Self-directed and strong ability to work effectively across multiple cultures and with cross-functional teams
- Participates as a member of the senior leadership team and plays a critical role in strategic decision
- Strong interpersonal skills with a special focus on customer satisfaction.
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.