Senior Manager, GxP Compliance Operations - United States
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
- Provide operational support across GxP Audit disciplines, including generation of metrics, consolidation of Master Audit and Working schedules, maintenance of information repository and continuous improvement.
- Participate in definition and execution of Celgene processes and requirements for Health Authority Inspection Management, participate in delivery of related training and provide onsite Inspection Management support when required.
- Serves as subject matter expert within the unit.
- Contribute to development of key audit-related compliance metrics (audit observation metrics); generate routine and ad hoc reports.
- Generate Audit and Inspection CAPA Tracking/Status reports.
- Participate in overall Departmental efforts to analyze internal metrics, identify and characterize issues, determine root cause, and plan improvement activities.
- Support collaborative efforts (with Regional/Audit Leads) to consolidate research and assess implications of emerging regulations, guidances, and industry standards.
- Responsible for ensuring quality of work performed.
- As a team member, independently executes high risk elements of the audit/inspection/compliance projects.
- May participate in or lead cross functional teams.
- Assists in the development of the department training plan; trains and develops junior staff.
- Leads audits/inspections/compliance projects of broader scope and greater complexity.
- May provide guidance/recommendations to clients re business practice or compliance issues.
- Provides input to audit/inspection criteria, programs, and plans.
- Contribute to the development and implementation of Standard Operating Procedures.
- Regularly leads multi-discipline audits/inspections projects.
- Must be able to multi-task required work for the role, in addition to ad-hoc/department projects.
- Manages inspection teams or leads 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.
- Minimum of B.S.
- Minimum seven years of relevant GxP pharmaceutical/biotechnology experience, including minimum four (4) to six (6) years of Compliance related or auditing experience
- Advanced subject matter expert in the required technical knowledge and expertise.
- Ability to analyze emerging compliance issues and recommend strategies to manage compliance risks.
- Serves as technical expert within job function.
- Has conceptual understanding of all applicable functions and business areas.
- Considers and incorporates global perspectives and requirements.
- Demonstrates adaptability.
- Comfortable with ambiguity and can adapt style and tactics based on situation and tactics based on the situation.
- Effective written and verbal communications.
- Express self clearly and accurately in written and verbal form.
- Balances diplomacy and respectfulness with assertiveness.
- Drives execution.
- Focuses on achieving objectives within specified timeframe 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.
- Ability to lead cross functional and diverse teams and participate constructively in multi-discipline teams.
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.