Director, GMP/GDP Compliance - 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.
1. PURPOSE AND SCOPE OF POSITION:
This position is responsible for design, development and implementation of global quality and compliance programs and processes within Celgene GMP/GDP functions. The position supports the continued operations and supply of quality products to the patient and plays a key role in addressing quality and compliance issues and risk.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have expert GMP, Quality, and risk management knowledge. Must have a comprehensive understanding of Good Manufacturing Practices (GMP) regulations and guidances (ICH, CFR, PIC/S, EU, etc.) as related to Pharmaceutical and Biotech Manufacturing.
- Must be able to critically interpret problems and effectively communicate in an impactful manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy.
- Must be a technical/scientific expert. Must be able to measure technical/scientific attributes in qualitative ways and drive science based decisions across the organization.
- Must manage technical teams across the organization.
- Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single project or collaboration.
- Must be skilled in strategic thinking, managing through systems, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.
- Demonstrated ability to effectively develop, communicate and gain support for strategic plans from wide range of stakeholders.
- Global pharma operational experience and working knowledge of regulatory and operating requirements in a global setting.
- Expert understanding of tools and approaches to assess and mitigate risk.
- Demonstrated project management skills with a proactive approach to issue identification and resolution.
- Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.
- Coach and develop other team members.
- Ability to work effectively across functional groups and teams to ensure requirements are met.
- Ability to make independent and objective decisions and to work with minimal supervision.
3. DUTIES AND RESPONSIBILITIES
- Develop and implement processes for quality/compliance issue/risk identification and escalation as applicable.
- Develop, implement and monitor applicable GMP/GDP quality and compliance KPIs; implement processes for addressing identified trends.
- Establish processes to ensure GMP/GDP quality risk management information, assessments, data, etc. is available to all required stakeholders, including applicable project teams, operational excellence teams, leadership, etc.
- Create and oversee execution of quality and compliance issue/risk mitigation strategies and plans.
- Lead quality issue/risk mitigation teams, provide direction, guidance and leadership to effectively mitigate issues/risks.
- Coordinate with global risk management team to ensure integrated end to end coverage of risks and coordination of monitoring, assessment and other activities.
- Direct the implementation of compliance activities within area of responsibility by guiding teams on accurate and timely responses to risks.
- Work in close collaboration with the other Risk Management Functions to ensure consistency in risk assessment, management, mitigation and continuous review.
- Develop, implement and oversee quality risk management program per ICH Q9 and other applicable industry guidance across GMP/GDP functions to support the continued oversight and assurance of product quality and compliance.
- Ensure appropriate application of GMP/GDP quality risk management principles within GMP/GDP operations including Quality, Development, Facilities/Equipment/Utilities, Materials Management; Production; Laboratories; Packaging/Labeling and other applicable GMP/GDP operations.
- Identify and deploy applicable quality risk management methods and tools facilitated by electronic systems and statistical tools as appropriate.
- Develop and deliver training on the use of quality risk management methods and tools to ensure consistency in application. Provide guidance and oversight to the organization regarding use of the methods and tools.
4. EDUCATION AND EXPERIENCE
- Relevant college or university degree required; advanced degree preferred.
- 8-10 years of relevant experience, a minimum of 8 years in a GMP regulated biotech and/or pharmaceutical environment
5. WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
SPECIAL CIRCUMSTANCES – WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS
• Minimum Travel required (<10%)
6. DEFINITIONS AND ABBREVIATIONS (As Applicable)
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to
describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.