Celgene Senior Manager, GVP Corporate Audit - UK or US based in Stockley Park, United Kingdom
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.
This role consists of primarily auditing against Good Pharmacovigilance Practice (GVP) regulations and guidelines. Audits include Celgene Affiliates, Partners and Vendors; as well as key Processes/Systems e.g. Case Processing, Aggregate Safety Reports and Risk Management Plans.
Auditors are responsible for the planning, conduct, reporting and verification of audit related commitments throughout the audit lifecycle until closure including maintenance of the PSMF sections related to audits.
Other responsibilities will include participating in projects within both the GVP Corporate Audit group and the Corporate Audit and Inspection Group; projects may include but are not limited to process improvement initiatives and strategic innovation opportunities.
The ideal candidate will have strong background knowledge of all Pharmacovigilance responsibilities undertaken by a Marketing Authorisation Holder and the quality background to ensure audits are conducted efficiently and in accordance with the GVP Corporate Audit group expectations.
Please note, that on average, 25% domestic and international travel will be required. This role can be based at our UK (Stockley Park) or US (Summit, NJ) offices.
Role and Responsibilities
Serves as a subject matter expert within the unit.
As the lead, plans and executes highest risk, most complex Audits/compliance projects under minimal supervision.
As a team member, independently executes high risk elements of the audit/compliance projects.
Must be able to multi-task the required work for the role, in addition to ad-hoc / department projects.
Supervises and provides guidance to unit colleagues beyond just a team / audit / project setting.
May mentor colleagues and be viewed as a leader/mentor.
Assists in the development of the annual audit plan (where applicable).
Assists in the development of the department training plan; trains and develops junior staff.
May provide guidance / recommendations to clients re: business practice or compliance issues.
Provides input to audit / inspection criteria, programs, and plans.
Maintain audit database for observations and audit CAPA.
Contribute to the development and implementation of Standard Operating Procedures.
Skills and Experience required
Minimum of a Bachelors Degree.
Extensive relevant GxP experience, including solid Compliance related or auditing experience (or equivalent).
The ability to be an advanced subject matter expert in the required technical knowledge and expertise.
Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
Competencies associated with this role
Considers and incorporates global perspectives and requirements.
Ability to lead cross-functional and diverse teams and participate constructively in multi-discipline teams.
Comfortable with ambiguity and can adapt style and tactics based on situation.
Balances diplomacy and respectfulness with assertiveness.
Focuses on achieving objectives within specified timeframes and to meet quality expectations.
Ability to participate constructively on cross-functional and diverse teams.
Willingness and ability to identify and investigate areas of potential risk; healthy skepticism.
Promotes open communication and is able to build consensus.
Demonstrates negotiation and conflict management skills.
Ability to independently and effectively communicate audit/inspection scope and results to management of affected business units.
Engagement planning and management toward timely and quality completion of objectives.
Training and coaching skills.
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.