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.
1. PURPOSE AND SCOPE OF POSITION:
This position is responsible for globally harmonized GMP/GDP compliant quality systems in support of Celgene’s GMP and GDP operations. Serves as the global owner for key quality systems and processes.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have expert GMP/GDP, Quality, and risk management knowledge that impacts the department or global function. Must have expert knowledge in global quality trends.
- Must have a strong level of communication skills. Must be able to effectively communicate in an impactful manner to management, the group, the broader organization, and executives.
- Must be a technical/scientific expert. Must be able to measure technical/scientific attributes in qualitative ways and lead science based decisions across the organization.
- Must manage and drive technical teams on impactful projects across the organization.
- Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single project or collaboration. Must act as an advisor to the executive team on impactful technical topics.
- Must be skilled in strategic thinking, managing through systems, navigating politics, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition.
- Extensive experience with successful deployment of global IT systems in support of quality systems and processes. Proven track record at identifying, obtaining funding for, initiating, overseeing and implementing IT system projects.
- Advanced understanding of GMP/GDP quality systems requirements.
- A strong communicator who is able to work with all levels of the organization; Excellent listening and interpersonal communication skills to identify stakeholder needs and drive balanced solutions.
- Demonstrated initiative, creativity, strategic capabilities, and ability to work effectively in complex, rapidly changing environments.
- Proven track record in leading an organization including; coaching, motivating and development planning.
3. DUTIES AND RESPONSIBILITIES
- Develops, implements and maintains effective and compliant Quality Management Systems globally across the GMP/GDP functions.
- Leads the following functions and is accountable for ensuring GMP/GDP compliant processes and quality systems for: Product Quality Complaints; Change Management; Deviation/CAPA; GMP Document Management; GMP Training; ERP Quality; Laboratory Systems.
- Global Business Owner for the Quality Analytics and Decision Support System.
- Sponsors and oversees IT capital projects in support of GMP/GDP Quality Systems; ensures delivery on time and within budget.
- Provides leadership for the global GMP/GDP education and training program and reviews/approves relevant content.
- Leads continuous process improvement efforts across the global GMP/GDP businesses to ensure quality and compliant processes and products.
- Provides effective Quality leadership during internal and health authority inspections of quality systems and processes.
- Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities.
- Plan, develop and administer the annual expense/capital budget and meet agreed spending targets.
- 4. EDUCATION AND EXPERIENCE
- Relevant life sciences, chemistry or engineering college or university degree required; advanced degree preferred.
- Minimum of 12 years related experience in GMP/GDP environment. Minimum of 10 years management responsibility in a regulated 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.
- 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.
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.