Senior Manager, Clinical Quality Assurance, Audit & Inspection

Celgene Corporation - Summit, NJ (30+ days ago)4.0

Other Locations:US- NJ- Summit West

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 key member of the CQA Audit and Inspection team, this position is responsible for leadership, planning, conduct, and reporting of GCP audits in order to ensure that clinical trials are conducted in compliance with applicable international regulations, guidelines, and global company standards. This role also has responsibility for preparation, management, and follow-up of global Health Authority (HA) GCP inspections, and provision of quality oversight and consultation at the clinical study or program team level in support of proactive quality management. This individual actively leverages audit / inspection outcomes / trends to effect improvement in clinical trial quality and compliance with Celgene and global regulatory requirements. Responsibilities also include leading and/or contributing to identification, development, implementation, management, and enhancement of CQA operational processes, systems, tools, and best practices.

Responsibilities at any time will include—however are not limited to-the following to support department priorities/deliverables:

Audit Planning, Conduct, Reporting, and Follow-up

Assess/plan and/or perform GCP audits of clinical investigator sites, vendors, internal systems/processes, and clinical documents
Review and/or prepare timely well-written audit reports and communicate findings to auditees, cross-functional representatives and management
Assess/review audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate
Review/evaluate and maintain/track CAPAs and follow-up with stakeholders to ensure actions are completed
Lead/perform for‐cause audits or other high profile audits, projects and/or special investigations to evaluate noncompliance, root cause identification, and report results to leadership
Lead/participate in audit report review team/process to promote consistent delivery of an optimally impactful ‘top quality’ report/product
Health Authority Inspection Planning, Preparation, Management, and Follow-up

Lead/participate in planning/preparation/conduct/follow-up for Health Authority GCP inspections
Lead/contribute to HA Inspection dossier preparation and document compilation/QC
Ensure creation/maintenance of documents for pre-inspection preparation
Oversee/conduct/coordinate training for defined SMEs and ensure setup of pre-inspection preparation meetings for line unit heads and appropriate staff
Lead/contribute to assessment of reports and results from Health Authority Inspections, including the associated risks and recommendations, for provision to relevant leadership
Oversee/participate in preparation of final response documents for Site Inspections and Sponsor/Monitor Inspections
Lead/collaborate with other CQA team members to complete inspection follow up activities within and outside department as needed
Oversee/ensure tracking/maintenance of CQA-managed Health Authority inspection data
Clinical Program/Study Quality Support and Consultancy

Maintain ongoing awareness of program/study issues related to quality, safety and efficacy
Provide quality oversight and consultation at program/study level [Refer to Core Competencies document for level differentiation]
Provide risk identification/mitigation support for potential or identified quality issues
Leverage audit/inspection trends and other information sources to support data-driven audit planning and optimize clinical trial quality and compliance via stakeholder education and consultation
Provide GCP compliance consultation to stakeholders on process enhancement/compliance and quality issue management
Appropriately escalate any quality/compliance issues to relevant leadership
Contribute to development/maintenance/provision of GCP and Inspection Readiness training for cross-functional stakeholders
Talent Development/Management

[As applicable] Provide leadership, training, coaching, mentoring, and support for team members
[As applicable] Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables
[As applicable] Contribute to functional talent development and performance management processes for direct reports

Pursue/maintain current knowledge of applicable regulations, guidelines, and company standards
Evaluate impact of new regulations/guidances, as well as audit results/trends on the business and regulatory risks and provide ongoing guidance to CQA and stakeholder leadership
Lead/assess CQA operational processes, identify/support/implement process improvements to enhance team efficiency/effectiveness
Contribute to the identification and communication of lessons learned from audits and inspections and provide expert advice/information to CQA and CRD staff
Lead/participate in CQA and cross-functional (stakeholder) process-related initiatives/projects and facilitate/support implementation as appropriate
Lead/complete various assignments as directed by CQA Management
Travel 40-50%, domestic and internationally, as needed

Skills/Knowledge Required:
Minimum of BA/BS degree in relevant discipline or equivalent/relevant work experience
Minimum 5 years of clinical quality assurance auditing and 5 years of work experience in clinical research and/or a GCP-related quality assurance environment
High degree of computer skills including proficiency with Microsoft Word, Excel, PowerPoint and Outlook are essential and knowledge of other Office applications helpful.
Strong organizational and time management skills
Ability to prioritize and multi-task successfully in a fast-paced environment
Responds flexibly to shifting demands and changing priorities, proactively looking for ways to contribute
Demonstrates attention to detail and high quality while meeting deadlines and commitments
Collaborates with team members across functions and geographies to get work done while encouraging others to do the same
Maintains optimism and composure in times of change, uncertainty, or stress
Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
Demonstrates critical thinking, sound judgement, and initiative to solve problems
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.