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, âquest 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.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Must have GMP, Quality, and in-depth risk management knowledge.
- Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
- Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function;
- Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
- Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
- Leads teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams; emerging as a leader contributing to Celgene culture and values.
- Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
- Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
- Scope of problem solving includes direct reports. Critically assesses project(s) and allocates resources to efficiently achieve goals. Implements solutions independently. Develops employees.
- Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
- Manages conflict and issues with internal and external customers. Demonstrates negotiation skills in internal and external cross-functional teams. Demonstrates coaching skills.
DUTIES AND RESPONSIBILITIES:
- Supervises and manages daily activities of the Batch Review/Disposition groups located at Warren, NJ facility. Assures job objectives are met on a timely basis.
- Manages all disposition activities for incoming production materials and drug product.
- Responsible for oversight of QA shop floor program.
- Oversee document issuance process for production batch records and product labels.
- Updates and procures approval of job descriptions for department personnel. Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages and motivates staff. Writes and administers performance appraisals for department personnel.
- Assures timely review of documentation for manufacturing operations batch records and QC testing.
- Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.
- Compiles and coordinates Quality Operations site batch review metrics for presentation to senior management via Management Review process.
- As required, performs Quality Operations review and approval for internal change controls, deviations, customer complaints, CAPAs and documentation changes.
- Supports site teams to compile the Annual Product Review/Global Product Quality Review Summary for Celgene product manufactured.
- Supports RA CMC request for site documentation to be included in Regulatory Authority product submissions and coordinates site SME review of these submissions to ensure filing timelines are met.
- Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
- Performs supplemental investigations/projects as required by senior management.
EDUCATION AND EXPERIENCE (As Applicable):
- Relevant college or university degree preferred.
- Minimum 7 years relevant work experience and minimum 4 years of leadership experience
- Equivalent combination of education and experience acceptable.
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.
#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.