Sr Director, Quality 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 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.
- Responsible for providing leadership and functional oversight of Philadelphia Site Quality Operations functions (Quality Assurance and Quality Control) and ensuring company’s adherence to quality policies, practices, standard operating procedures (SOPs) and regulatory requirements, as described in current Good Manufacturing Practices (cGMPs).
- Ensure effective implementation, maintenance and continuous improvement of GxP Quality programs and infrastructure to support Contract Development and Manufacturing Organization (CDMO) (Philadelphia, PA).
- Collaborate with site and senior management to ensure the site operations remain in compliance with Quotient requirements, regulatory and statutory requirements, industry guidance and best practices.
- Collaborate with other leaders, within and outside of Quality, to build relationships, meet customer expectations, drive business results, deliver quality products and services right the first time, and provide a consistent customer experience across Quotient.
- Provide leadership that visibly demonstrates quality and compliance as a top priority, focuses on prevention, and fosters a culture where quality is a core value.
Main tasks and responsibilities will include:
- Provide a strong strategic and practical management of the GxP aspects of Quotient’s Philadelphia sites Operations and overall quality related activities to ensure continued compliance with applicable global regulatory standards.
- Work closely with global/matrix leaders to deliver Quotient’s strategy and business objectives and deliver business growth in line with the business plan.
- In collaboration with other Quality leaders, establish strategic plans for the Quality function and annual Quality objectives across sites that ensures delivery of the strategy.
- Facilitate a collaborative, inclusive and engaging environment that allows colleagues to succeed in their roles and achieve their highest potential. Coach and mentor team and encourage continued professional development. Conduct communication and feedback sessions through team meetings and one-on-one interactions to ensure colleagues receive appropriate direction, feedback and coaching for success. Develop robust talent and succession pipelines to develop and retain key talent and deliver business objectives.
- Continuously remain up to date with the latest industry changes to regulatory requirements and industry standards. Provide guidance and direction on GxP quality and compliance related issues internally and to customers.
- Ensure the Philadelphia sites are in a constant state of inspection-readiness to achieve successful outcomes of regulatory inspections from global regulatory agencies (e.g., FDA, EMA, ANVISA, JPAL). Proactively identify and work collaboratively to resolve compliance risks and maintaining effective procedures and processes. Participate in regulatory inspections and as required, lead the resolution of and response to any inspection findings. Ensure effective communication of inspection outcomes to relevant site and senior management.
- Ensure Quotient Sciences Philadelphia is recognized as an industry leader in quality and compliance by appropriately integrating efficient, compliant practices across all service lines.
- 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.
- Oversee Philadelphia sites GxP training programs to ensure colleagues at all levels are educated on regulatory requirements and expectations. Identify training requirements and develop and implement new programs where required.
- Monitor, analyze trends, and report on quality metrics to executive management on a regular basis, and identify and assure implementation of improvement initiatives.
- Drive efforts to ensure continuous improvement of processes that deliver enhanced results.
- Develop and grow relationships with customers to maintain highest levels of customer confidence in our quality systems, processes, and approaches. Ensure customer audit success and timely resolution of any identified issues.
- Develop and maintain strong relationships with relevant regulatory authorities, as appropriate, ensuring the business remains compliant with changes in regulations and expectations and aware of current trends.
- Ensure overall resource levels are appropriately maintained to support business demands and that colleagues are deployed for maximum productivity.
- Develop and promote a positive quality culture within the Philadelphia sites workplaces and drive continuous improvement focused on quality and regulatory compliance and right-first-time execution while maintaining an environment of open communication.
- Encourage and promote participation and intra/inter-departmental idea sharing to build an engaged team. Model Quotient’s leadership expectations and principles and ensure the highest level of compliance and integrity are adhered to in all interactions. Ensure Quotient’s manifesto, behaviors and core values of Science, Agility and Culture are embedded and sustained.
- Demonstrates sound judgment, goal-oriented actions, and work in collaboration with others.
- Establishes an environment that fosters diversity and encourages teamwork.
- Work with Finance to establish annual budget including labor resource planning. Monitor monthly performance against budget with aim of achieving/exceeding target(s). Report on variances and their cause(s) and provide proactive communication of anticipated future variances to plan. Participate in annual pay review process for Quality colleagues. Anticipate and plan capital expenditure requirements with justification and return on investment analysis. Review and approve expenditures in line with company policy.
- Perform other duties as assigned.
- Bachelor’s degree in science or a related field; advanced degree preferred. Extensive line management experience and significant experience in pharmaceutical or related industry with demonstrated increasing responsibilities and experience in quality or compliance.
- Expert knowledge and demonstrated hands-on capabilities with implementing and maintaining GxP systems and processes that support right-first-time execution and sustained compliance.
- Must possess strong written and oral communication skills, ability to influence change / be a change agent, and be able to coach, mentor and train others.
- Proven record of developing and maintaining successful working relationships with regulatory agencies
- Able to persuade and influence in line with our culture and company behaviors and ensure strong compliance mind-set is embedded across the organization.
- Ability to manage performance of the function across multiple sites and deliver results. Skilled in thinking and acting strategically.
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.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.