Celgene Associate Director, Clinical Quality Management – Procedures and Training in Berkeley Heights, New Jersey

Description

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:

The Associate Director, Quality Management – Procedures and Training is responsible to support the development of policies, SOPs, working instructions, forms, templates, guidelines and training materials related to clinical studies and clinical systems to ensure alignment with global regulations and guidelines and good documentation/writing practice. This position will liaise with Clinical QA, IT QA and Compliance with regards to policies and procedures as well as audits and inspections. He/she will support the Director in the development of procedures and preparation/implementation of authoring guidelines and good documentation practice. He/she will support CAPA responses within Global Clinical R&D Operations (GCRDO) and will ensure adequate responses prior to finalization. This role supports clinical study teams with training and guidance related to GxP processes and systems to ensure quality.

Responsibilities include, but are not limited to:

  1. Supporting the development and approval of all documents related to clinical study processes and systems including but not limited to SOPs, WPs,

  2. Supporting cross-functional colleagues with internal and external audits and leading CAPA responses in collaboration with the business

  3. Identifying need for/developing policies, in collaboration with cross-functions, that outline global standards

  4. Leading and/or attending procedural committee meetings

  5. Providing training and guidance to clinical study teams for GxP and review training materials to ensure adequacy and alignment to industry best practice

  6. Assisting in inspection readiness / training of study teams.

Leadership Competencies:

  • Fosters teamwork

  • Proactive shares information, ideas, input and/or expertise with team members and encourages others to do the same

  • Collaborates with people from other teams, functions, and geographies as needed to get work done

  • Handles conflict with others in a constructive manner

  • Fosters risk taking

  • Encourages others to suggest a new idea or methodology and appropriately analyzes risks and benefits prior to implementation or suggestion

  • Displays a willingness to challenge the status quo but provide business rationale/benefits for taking the risk/approaching something in a new way

  • Demonstrates 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

  • Deals constructively with mistakes and setbacks

  • Maintains a high level of performance in the face of ambiguity or change

  • Accepts challenging assignments and new responsibilities

  • Promote open communication

  • Clearly articulates ideas, opinions, and information

  • 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 of the organization

  • Develops and maintains strong working relationships with people across cultures

  • Attract and develop talent

  • Routinely asks for feedback from others

  • Uses both positive and negative feedback to enhance performance

  • Learns from both successes and failures

  • Seeks both formal and informal development opportunities

  • Serves as a resource for other’s development

  • Shape strategy

  • Demonstrates basic understanding of the external environment and its implications for Celgene’s goals and strategies

  • 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

  • Continually works to improve products, services, and work processes

  • Identifies and/or supports new solutions, opportunities, and initiatives

  • Drive execution

  • Sets individual goals aligned with team, functional, and corporate goals

  • Stays focused on highest priority activities, effectively managing time and workload

  • Maintains high quality while meeting deadlines and commitments

  • Holds self accountable for actions and results

  • Demonstrates a concern for the needs and expectations of internal and/or external customers

#LI-POST

Qualifications

Skills/Knowledge Required:

  • BA/BS or equivalent degree preferably in life sciences or allied health field

  • At least 10 years of global experience working in quality assurance, quality control and/or quality management

  • Strong experience authoring policies and procedures in the pharmaceutical/biotech industry

  • Knowledge of GxP and global regulations preferred; Direct experience with clinical trials is a plus

  • Experience working with global, cross-functional teams

  • Ability to problem solve and work independently

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.

Associate Director, Clinical Quality Management – Procedures and Training

Location: Berkeley Heights, NJ, US

Job ID: 17001104