Director, Development Systems - Drug Development & Devices
Other Locations: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.Director, Development Systems - Drug Development & DevicesSummit, NJ
PURPOSE AND SCOPE OF POSITION:
Reporting to the Head of Device & Combination Product Development, the Director, Development Systems, is responsible for providing guidance and leadership for Development Systems including document storage, good documentation practices, knowledge management and data governance. The Director will serve as an SME to compound, biologic and device development teams, ensuring consistent implementation of good documentation practices and developmental stage-gate document requirements. The Director will establish new systems including electronic Design History File (eDHF) and requirements flow-down management as well as maintain new and upcoming document archives for development documentation.
The Director will be the head of the Development Systems (DevSys) Center of Excellence (COE) providing Systems, Data Governance and Knowledge Management expertise across Pharmaceutical Development, Biologic Development, Device & Combination Product Development and Companion Diagnostics. The role will be responsible for building a team of engineers and specialists tasked with providing direct project team support for all development systems related documentation including GMP activities (deviations, change controls, etc…).
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have a strong technical/scientific aptitude with an ability to measure attributes in qualitative ways and drive science based decisions across the organization.
- Diverse industry knowledge of the regulatory and compliance requirements for pharmaceutical, biologic and medical device development (specifically, 21 CFR Part 210, 21 CFR part 600, 21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971).
- Must be skilled in strategic thinking, managing through influence, innovation management, and negotiation.
- Must possess a global perspective and leadership disposition with a desire to work in a highly collaborative, cross-functional team environment
- Must be interested and willing to build and mentor a technical organization with a focus on strong subject matter expertise and collaborative leadership.
- Must be comfortable working in a dynamic and highly innovative environment.
- Must have prior experience implementing and maintain development systems.
- Must have a strong understanding of industry trends in data integrity and apply these principles across Development.
- Must have prior experience with leading/owning GMP investigations and changes.
DUTIES AND RESPONSIBILITIES
- Knowledge Management & Data Governance:
- Define and implement a development systems documentation strategy for biologic and device development.
- Drive harmonization of development documentation systems across the primary development functions including PharmDev, BioDev, CDx and DeviceDev.
- Own critical data management processes and policies including data governance, data accuracy and data integrity across development platforms.
- Function as GPDO lead/representative on all data and knowledge sharing initiatives and councils
- Harmonize key terminology and meta-data across development functions to enable seamless data sharing and communication.
- Own the Development Systems information and data archives.
- Support the Development Orgs in meeting the requirements of the Celgene QMS in conjunction with Quality.
- Own risk management for product development.
- Own the support model for GMP investigations and changes within Development.
- Ensure Product Development Teams (PDTs) are applying good documentation practices and meeting the timing/deliverables defined per Stage Gate.
- Assist in the development and lifecycle management of procedures and systems including Design Controls, Risk Management, Requirements Management, Development Documentation and Stage Gate Deliverables.
- General Responsibilities:
- Implement a resource plan focusing on the development of a talented technical team composed of Engineers and Specialists that can achieve the mission and vision of Global Pharmaceutical Development and Operations.
- Continuously develop and provide mobility for leaders within Celgene while ensuring a robust pipeline of talent and succession planning.
- Actively participate in industry associations, conferences and forums, remaining current on emerging technologies, market trends and changing regulations/standards.
- Ability to travel up to 15% globally.
EDUCATION AND EXPERIENCE
College or University degree required; advanced degree preferred. Technical degree focus areas are strongly preferred including engineering (mechanical, biomedical and/or systems) and natural/physical science (chemistry, biology and biochemistry). Minimum 12 years relevant work experience, specifically in the regulated healthcare space (pharmaceutics, biologics or medical devices). Minimum 5 years of leadership experience.
#LI-POSTCelgene 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.