Director, Clinical Quality Management, Procedures

Berkeley Heights, NJ US
Competitive Salary
Oct 07, 2016
Nov 04, 2016
Clinical, Quality
Result Type
Position Type
Full Time

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 Director, Clinical Quality Management – Procedures and Training is responsible to lead and oversee 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 supervise individuals involved in development and quality of procedures and will be responsible to oversee preparation and implementation of  authoring guidelines and good documentation practice.  He/she will lead 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. Overseeing development and approving 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. Supervising individuals involved in process development and training 4. Identifying need for/developing policies, in collaboration with cross-functions, that outline global standards 5. Leading and/or attending procedural committee meetings 6. Providing training and guidance to clinical study teams for GxP and review training materials to ensure adequacy and alignment to industry best practice
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 or                 quality management  • Strong experience authoring policies and procedures in the                                 pharmaceutical/biotech industry • Knowledge of Computer System Validation requirements and clinical                   systems • Line management experience, with strong awareness of personnel training         needs assessment and individual development and performance                         management • Experience managing and collaborating in a team/matrix environment • Strong collaboration skills and experience working with teams cross                     functionally and globally • Ability to problem solve and work independently
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 effective 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
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.