Director, Clinical Quality Assurance - Summit, New Jersey
Director, Clinical Quality Assurance
Req #: 16001543
Location: Summit, NJ US
Job Category: Quality
Work Location: Summit West
Organization: Celgene Corporation
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Director
Travel: Yes, 25 % of the Time
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.
As a leader in the CQA Quality and Process team, this individual is responsible for providing global leadership in contributions to strategic planning, development, implementation, and management of Clinical Quality Assurance and Data Sharing/Disclosure operational processes, systems, tools, and best practices. The position is responsible for such systems within CQA and all cross-functional organizations involved in clinical research activities in collaboration with matrix and CRO/vendor partners, as appropriate.
Responsibilities include development and management of direct reports to ensure individual/team accountability and high performance. This individual actively leverages audit/inspection outcomes/trends to effect sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance in Celgene clinical trials (Ph I-IV) and with Celgene and global regulatory requirements in support of CQA and Corporate objectives
Responsibilities at any time will include all or a component of the following to support department priorities/deliverables:
Quality and Process Leadership / Functional Excellence
- Leads the development/enhancement, implementation and maintenance of the CQA Quality Management System and oversees associated activities
- Responsible for oversight and leadership of CAPA program and quality risk management to enable timely identification and communication of compliance issues/risks, including trend analysis and quality metrics review to foster optimized compliance and continuous process improvement
- Develops and presents periodic reports describing quality/compliance metrics/trends and identifying areas of potential risk to senior management
- Leads/promotes leveraging of audit/inspection results to effect sustained improvement/correction/compliance through robust root cause analysis, CAPA implementation/tracking, and reporting/communication of lessons learned to broader organization
- Actively drives strategy for process development/ implementation/ compliance for department as well as across functions supported by CQA.
- Provides GCP compliance consultation to clinical teams and other stakeholders on process enhancement/compliance and quality issue management, ensuring consistent quality standards and fostering strong working relationships
- Leads vendor quality oversight activities and serves on any assigned operational and/or governance committees
- Oversees administration of SOPs/WPs which facilitate execution of both in-house and outsourced clinical trials/programs compliant with ICH/GCP standards
- Ensures GCP/SOP/Inspection Readiness training programs are maintained and provided as appropriate to all global staff supporting clinical trials
- Provides oversight for GCP, SOP, and WP training compliance for staff within CQA Training Administration remit
Quality Assurance Audit and Inspection Leadership
- Actively contributes [as member of leadership team] to the strategic, risk-based planning of CQA audits and assessment activities including definition/implementation of short and long term CQA goals in support of regulatory filings and other milestones
- Provides leadership to ensure that CQA audits are conducted and reported in compliance with CQA standards, associated CAPA are identified/implemented in a timely manner, and findings are communicated to relevant management/stake holders with the appropriate level of urgency
- Leads/Facilitates global HA inspectional activities [including preparation, management, response, and follow-up], coaches staff on specialized investigations/projects and provides assessment of reports and results from Health Authority Inspections, including the associated risks and recommendations to relevant management
- Ensures consistency of auditor training and QA audit activities, including CAPA and follow-up
- Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables
- Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements
- Facilitate functional talent development and performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plans are established
- Support the planning and management of the departmental operating expense budget to ensure targets are achieved according to expectations
- Leads or participates on global and/or cross-functional work groups, task forces, teams, initiatives, etc.
- Exemplifies and promotes Celgene values and behaviors during all CQA activities
- Travel 25-30%, domestic and internationally, as needed
- B.S. and/or M.S. in Chemistry, Biology, or Health related field
- Proven progressive responsibility in biopharmaceutical, GCP-related quality environment with a track record of success in managing compliance or quality-related projects and teams
- Proven people management experience with demonstrated effectiveness as mentor, coach, and leader; ability to build and maintain a high performance team; ability to develop internal talent and hire/manage talented individuals
- Exemplary leadership / influence management skills with ability to foster partnerships in the matrix organization across functional/geographic/cultural/partner boundaries
- Solid understanding of financial/budgeting and resourcing principles and utilization of this knowledge to make sound business decisions.
- Expert knowledge of applicable global GCP guidelines/regulations and global drug development process
- Thorough understanding of the challenges relating to execution of global clinical trials and the importance of compliance
- In depth understanding of the overall audit process including design, conduct, reporting, and translation of findings into CAPAs that mitigate risks
- Experience in Quality Issue and CAPA management
- Experience in developing, implementing, and harmonizing Quality Management Systems is desirable
- Experience in regulatory inspection preparation, management, and related follow-up
- Excellent negotiation, decision-making, leadership and interpersonal skills
- Proficient at creating and communicating a clear vision among team members and effectively aligning resources/activities to achieve functional area and/or organizational goals
- Communication skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; strong presentation skills for effective peer and Senior Management communication
- Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
- Organizational/Time Management skills: Must be able to effectively prioritize, multi-task and work under pressure independently or as a member of a team
- Computer Skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members
Additional Leadership Competencies:
- Builds a culture of energy and commitment that challenges people to excel
- Places a priority on getting results with an emphasis on high quality outcomes
- Champions new ideas and approaches, moving them forward into action
- Anticipates future needs within the function when selecting and developing talent (e.g., develops successors and talent pools for key positions)
- Effectively evaluates the benefits and risks associated with moving forward with a new idea or methodology
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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