US- NJ- Warren
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.Sr. Specialist - QA Compliance / Audits Warren, NJ Manager
Manager, CompliancePrerequisites (As Applicable)
B.S. degree or the equivalent combination of relevant education or professional experience. Minimum of five years of relevant GMP/GDP pharmaceutical/biotechnology industry experience.PURPOSE AND SCOPE OF POSITION:
The Sr. Specialist is responsible for supporting the QA Compliance group by leading all audits (external and internal) and regulatory inspections that occur at the CTDO New Jersey facilities (Warren and S12) in order to assess compliance with all relevant regulatory and Celgene policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include identify Quality Risks through routine audit walkthroughs of GMP areas and facilities and review of Celgene procedures, performing gap assessments, managing the site Inspection Management Plan, performing approvals for manufacturing investigations, and driving proactive and corrective improvements within Operations.REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
DUTIES AND RESPONSIBILITIES
- Must have advanced knowledge and experience with cGMP manufacturing, Quality, risk management, and compliance.
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Must be able to prepare written communications and communicate problems to management with clarity and accuracy.
- Must be able to write and review reports with clarity and brevity. Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem identification/solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity.
- Good knowledge of all relevant regulations and deeper knowledge of relevant laws / regulations in GMP/GDP area(s); ability to translate regulations into operational requirements.
- Good knowledge of all relevant Company policies / procedures / standards with deeper knowledge of Company policies / procedures / standards in GMP/GDP area(s).
- Good knowledge of processes, management systems, products, services, data integrity, and technologies.
- Organization and planning abilities with attention to detail.
- Understanding of risk management and ability to evaluate an organization's risk exposure.
- Considers and incorporates global perspectives and requirements.
- Effective written and verbal communications.
- Drives execution.
- Engagement planning and management toward timely and quality completion of objectives
- Defines plan for audit conduct and determines seriousness of findings and risks; determines if and when to escalate risk or other aspects of audit to management.
- Training and coaching skills.
- Commitment to self-development and ability to stay abreast of internal and external requirements.
EDUCATION AND EXPERIENCE (As Applicable)
- Maintain inspection readiness for the site
- Lead preparation meetings with internal stakeholders
- Respond to any pre-audit requests
- Follows inspection management plan
- Conduct opening, daily debrief, and closing audit meetings
- Lead the execution and conduct of the audit.
- Ensure that findings and observations are identified, evidence is collected where possible, all potential critical observations are immediately identified, and expectations and next steps are identified.
- Escalate potentially critical observations and organize meetings with Head of QA Operations, other QA functions, Legal, Reg. Affairs and others to discuss critical or major findings and potential impacts.
- Review completed manufacturing investigation for adherence to procedures and drive continuous improvement to the investigation process.
- Assess global standards/policies and emerging regulations and provide gap assessments as needed.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Able to effectively multi-task.
WORKING CONDITIONS: (US Only)
- Minimum of B.S. or the equivalent combination of relevant education or professional experience.
- Minimum of five years of relevant GMP/GDP pharmaceutical/biotechnology industry experience.
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.
Associated topics: business, compliance, compliance department, compliance office, counsel, court, courtroom, internal, legal department, llp