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.
Sr Manager, QC Systems and Services
Purpose and Scope of Position
The Sr. Manager, QC Systems and Services, is responsible for oversight of daily activities pertaining to the support of the analytical chemistry and microbiology laboratories to ensure that all required activities are completed and documented in an accurate, consistent and compliant manner. Support of the microbiology laboratory includes product and raw material sample management, worksheet preparation and instrument operation procedures and qualification. Analytical chemistry laboratory support includes: procurement and qualification and maintenance of consumables, standards, instrumentation, methods and; method lifecycle support; coordination of the stability and retain programs; oversite of sample receipt, control and chain of custody; worksheet preparation and reconciliation; master data management for laboratory systems; shipment and tracking of samples to CSPs.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced understanding of pharmaceutical regulatory requirements and their impact to commercial laboratory operations.
- Advanced understanding of technical purpose and capability of laboratory instrumentation, software and techniques.
- Intermediate formal presentation skills for internal and external audiences.
- Advanced management and organizational skills.
- Advanced team and individual leadership skills.
- Intermediate proficiency in Microsoft Word, Outlook, and Excel.
- Intermediate project management skills.
- Advanced knowledge of global cGMPs, JP, USP, and EP.
- Advanced written and verbal communication skills.
- Ability to work independently for extended periods of time.
- Ability to effectively collaborate cross-functionally to drive effective communication.
Duties and Responsibilities
Oversee and coordinate QC control center, systems and technical services group activities to ensure timely completion.
- Coordinate between global and site stakeholders and supervisors to oversee routine activities of QC control center, systems and technical services groups.
- Ensure timely communication QC Incoming, Analytical Chemistry and Microbiology groups regarding prioritization of support activities.
- Determine and communicate priorities to control center and systems and services groups.
- Effectively delegate tasks.
Oversee review and approval of documents to ensure appropriate documentation of data and changes.
- Ensure compliant and consistent review and approval of testing data and supporting documentation ensuring consistent use of data integrity principles.
- Evaluate, coordinate and oversee action item assignments related to change control.
- Perform cross-functional review and approval of document changes for SOPs, methods, protocols, specifications, and other technical documents.
- Mentor group members regarding the impact of changes ensuring appropriate evaluation with regard to both internal and external processes.
- Mentor group members on appropriate documentation for exceptions, justifications and risk assessments.
Coach and develop group members to ensure they have the skills and abilities to perform the duties assigned to them.
- Drive sense of team responsibility for group’s success. Develop and sustain self-directed work teams to support team ownership of effectively and efficiently completing activities.
- Participate in hiring processes internal and external to the group.
- Determine group training curricula and oversee development of training content.
- Provide feedback to direct reports through regular coaching sessions.
- Utilize company-guided performance management tools and processes.
- Ensure group members have and use appropriate engineering controls, safety procedures and PPE. Encourage a strong culture of team and individual safety awareness and accountability.
Coordinate cross-functionally globally and across the site to support project planning and execution.
- Participate in initial project planning to comprehensively ensure requisite resources and technology are included.
- Ensure appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed.
Perform analyses and determine appropriate actions with regards to investigations, deviations, CAPAs, and continuous improvement to ensure continued compliance with all cGMP requirements.
- Anticipate and troubleshoot issues with regards to processes, procedures, documentation, instrumentation and electronic systems.
- Use a scientifically sound, risk-based approach to determine impact and root cause of issues identified.
- Develop and implement corrective actions.
- Lead and develop best practices.
- Mentor group members for ongoing continued growth in technical troubleshooting using effective scientific methods.
Performs other tasks as assigned.
Education and Experience
- Bachelor’s degree required.
- 9 years of relevant work experience required, preferably in a regulated industry.
- 3 years leadership experience required.
- An equivalent combination of education and experience may substitute.
- The incumbent may be required to type for up to 4 hours per day.
- The incumbent may be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 2 hours, up to approximately 5 times per week.
- The incumbent must be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
- The incumbent must analyze numerical values and technical details on a daily basis.
- The incumbent will occasionally be working in a laboratory setting up to 2 hours per day.
- The incumbent will occasionally be working around hazardous materials to include chemical agents up to 2 hours per day.
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.