Manager, Clinical Quality
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.
The individual in this position will perform activities related to development and management of procedures, management of corrective and preventive action plan follow-up, management of timely reporting and maintenance of role-based training plans.
Key responsibilities include, but are not limited to, the following:
Development and Management of Procedures/Tools/Templates/Forms
•Develop processes and tools such as author guidelines and process flows and support author training to ensure timely and quality procedure preparation
•Manage procedures, forms and templates related to clinical trials to ensure quality and timeliness
•Track metrics and prepare reports for management related to cycle times and quality
•Support internal audits related to clinical processes and systems
Management of CAPAs
•Support internal audits related to clinical processes and systems, collect documents and prepare communications to individuals impacted regarding timing and requirements
•Manage CAPA follow-up by working closely with assigned business owner to ensure timely completion
Maintenance of Training Plans
•Maintain role-based training plans in support of departmental line management
•Ensure that trainings are updated in the Learning Management System and match the role-based training plans
•Generate or support generation of training materials inclusive of relevant user guides or job aides that define data collection and reporting standards
•Monitor training effectiveness and update materials/re-train as needed to support continuous improvement and meet business needs
•Develop and implement system processes that complement the business practices enabled via the system
BA/BS in life sciences or equivalent with at least 3 years of experience in global quality assurance working to develop procedures and training programs in support of quality systems
Skills/Knowledge Required: •Prior experience in quality assurance; global experience preferred •Strong understanding of regulations and guidelines related to quality systems and documentation •Strong attention to detail and ability to resolve issues collaboratively •Ability to interact across multiple functional areas, as well as countries, with keen attention to cultural differences
Leadership Competencies: Foster Teamwork – •Collaborates well with people from other teams, functions, and geographies •Handles conflicts with others in a constructive manner
Foster Risk Taking – •Displays a willingness to challenge the status quo in an appropriate manner
Demonstrate Adaptability – •Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute •Asks question to better understand the rationale for and benefits of change •Maintains optimism and composure in times of change, uncertainty, or stress •Deals constructively with mistakes and setbacks •Maintains a high level of performance in the face of ambiguity or change •Responds openly to feedback viewing suggestions as learning opportunities
Promote Open Communication – •Clearly articulates ideas opinions, and information •Listens to others’ viewpoints and asks questions to clarify for understanding •Encourages open exchange of information and viewpoints •Uses different communication methods appropriately (e.g., email, voice mail,face-to-face) •Promptly communicates information that others need to know in order to do their jobs
Create Global Mindset – •Considers global influences, situations, and implications both inside and outside the organization when making plans or decisions, solving problems, or developing strategies •Develops and maintains effective working relationships with people across cultures •Demonstrates cross-cultural sensitivity when working with others •Understands and utilizes knowledge of local business practices when working across cultures
Attract and Develop Talent – •Learns from both successes and failures •Seeks both formal and informal development opportunities
Shape Strategy - •Demonstrates basic understanding of the external environment and its implications for Celgene’s goals and strategies •Seeks to understand the company’s vision and strategies and how his/her work contributes to reaching it •Maintains focus on work that is most important to accomplishing Celgene’s operational goals
Drive Innovation - •Contributes openly and honestly when new ideas or initiatives are being debated •Evaluates others’ ideas and communicates both support and concerns in a professional manner •Continually works to improve products, services, and work processes •Identifies and/or supports new solutions, opportunities, and initiatives
Drive Execution - •Stays focused on highest priority activities, effectively managing time and workload •Maintains high quality while meeting deadlines and commitments •Keeps manager informed of progress and seeks guidance when deadlines or goals are in jeopardy •Demonstrates a concern for the needs and expectations of internal and/or external customers •Makes timely decisions based on accurate logic; looks beyond symptoms to identify causes of problems; makes decisions in the face of uncertainty; takes all important issues into account when making decisions. •Meets commitments to customers/clients; continually searches for ways to improve customer/client service; impresses customers with exceptional service or work; seeks feedback from customers. 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.