Celgene Sr. Manager, Investigational Material Supply Chain Compliance and Risk Management in Summit, New Jersey
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.
PURPOSE AND SCOPE OF POSITION
This position is responsible for conducting IMSC Compliance inspection readiness, execution, and closeout activities for Celgene sponsored trials. Working as a key member of the IMSC Compliance and Risk Management Team, the incumbent will proactively identify/report to management operational and systemic compliance issues and/or risks related to clinical supply chain end-to-end processes. The incumbent will also be considered a subject matter expert on Trial Master File and SOPs/Work Practices used by the Investigational Material Supply Chain department.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Strong team player who supports the department objectives
Strong sense of urgency
Strong oral and written communication skills
Appropriate conflict resolution and escalation skills
In depth knowledge of all phases, processes, and functions of drug development
In depth knowledge of investigational material supply chain
Strong background in cGxPs and ICH requirements
Strong analytical skills
Ability to handle multiple projects simultaneously with excellent prioritization skills
Demonstrated teamwork and collaboration skills
Ability to coach and mentor others
DUTIES AND RESPONSIBILITIES
Performs prospective checks to Identify operational and systemic compliance related issues both internally and externally.
May represent IMSC on inspection readiness committees.
Determine compliance impact of integration programs which may include performing an assessment of supply chain processes and components of the TMF.
Collaborate with functional areas to determine best solutions to resolve any identified compliance issues
Actively participates as a member of the designated Program Level Planning team (PLP) team during initial integration of the compound/program into the supply chain.
Lead IMSC personnel in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies.
Conduct root cause analysis to develop responses to audit and inspection findings.
Assess compliance with IMSC procedures and reports findings and process gaps. Identify and propose potential solutions.
Stay abreast of global Health Authority regulations for packaging, labeling, systems, distribution, and vendor management.
Develops and implements inspection readiness strategies.
May act as the main point of contact with Regulators for the clinical supply chain during audits and inspections.
Supports the strategic direction on developing, implementing compliance tools, processes, and metrics.
Maintains strategic business relationships with key stakeholders that meet the needs of corporate objectives, quality, and regulatory requirements.
Complete gap analyses on cross functional procedures to identify compliance risks with global Health Authority regulations
Supports assessment of changes to global regulations and determines impact to IMSC procedures.
Independently supports Recall/withdrawal activities
Identifies compliance risks with external departments’ SOPs and policies that may impact IMSC processes and guidelines.
May provide input into IMSC Risk Management Program inclusive of vendors, systems, etc.
After conclusion of an audit or regulatory inspection, leads cross functional “lessons learned” meetings to ensure continuous improvement of the audit/inspection preparation and execution process.
Independently perform proactive Trial Master File reviews to identify potential documentation and process issues
Exhibit strong communication, collaboration and conflict management skills to establish and maintain relationships with cQA and GTMM. Must be able to facilitate decision making, action and execution.
Liaise with cQA and GTMM to develop inspection readiness strategies.
Acts as a mentor to Level I, II III Compliance Specialists.
EDUCATION AND EXPERIENCE
BA/BS, 9+years’ experience in the pharmaceutical industry with at least 6 years’ experience in drug development, Clinical Operations, IRT and/or clinical supply chain management, and 3 years in GMP/GCP compliance and risk management.
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.