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.
Summary / Scope:
- Plans, conducts and follows up on GVP audits of assigned entities to assess compliance with regulatory and Celgene requirements; identify compliance risks and drive concurrence regarding their severity
- Contribute to planning and operational analyses for discipline
- Scope includes internal and external audits of global sites/affiliates, processes and vendors
- 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 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.
- Demonstrates the ability to multi-task responsibilities.
- 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.
- Minimum of Bachelors Degree
- Ten (10) plus years of relevant GxP pharmaceutical/biotechnology industry experience, including minimum four (4) to six (6) years of Compliance related or auditing experience (or equivalent)
- Advanced subject matter expert in the required technical knowledge and expertise.
- Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
- 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.
- Drives execution.
- Focuses on achieving objectives within specified time frame and to meet quality expectations.
- Fosters teamwork.
- 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.
Travel: Position requires about 25% domestic and international travel.
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.