CEL - DATA MANAGER
Job Number: 21-04187
Job Number: 21-04187
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Data Manager for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The CAR T Compliance Support Specialist supports the Summit West CAR T Warehouse Operations organization, managing sustained compliance across multiple department areas and across multiple shifts.
- The position is responsible for assessing process improvements and cGMP document updates, change control compliance, Deviation and CAPA management, process metrics, as well as supporting consistent communication to the department teams and staff members.
- The position will also partner with Warehouse Operations supervision / management to support Quality Assurance observations and audit responses and timelines.
- This position plays a critical role in the CAR T warehousing processes ensuring quality is intrinsic to the operation; appropriate controls are enabled, communications to staff are consistently delivered and warehouse operations are continuously improved.
- The CAR T Compliance Support Specialist interfaces with the different operations groups, collaborating with department and support functions to meet objectives and goals.
- The position assures compliance with all FDA, DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations and certifications including training, documentation, standard operating procedures and corporate policies.
- Advanced knowledge cGMP warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation and qualification
- Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
- Proficient knowledge of OSHA, DEA, USP and other applicable WH regulations
- Proficiency in ERP systems / WMS Applications and analytics tools
- Proficiency in system and application use for business operations
- Advanced proficiency in MS Office applications
- Advanced analytical, problem-solving, and critical thinking skills
- Advance project management experience handling multiple projects simultaneously
- Advanced organizational and time management skills
- Strong written and verbal communication skills
- Strong presentation development and delivery skills
- Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements
- Demonstrated proactive, high attention to detail and follow-through
- Ability to work with people at varying levels within the organization and varying skillsets
- Ability to work independently and manage multiple tasks / timelines
- Ability to travel 5% - 10% of time
- Bachelor's degree in supply chain, engineering, life sciences, information systems, business management or related fields. Advanced degree preferred.
- 10+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
- 7+ years experience in warehousing, quality, manufacturing and supply chain areas.
- Direct supervisory /personnel management experience preferred
- Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
- An equivalent combination of education, experience and training may substitute.
- Responsible for the adherence and administration of all Operating Procedures, protocols, policies, regulatory requirements, GMP guidance and safety guidelines.
- Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMPs, and safety.
- Manages and drives timely completion of department Deviations, CAPAs and Change Controls; serves as SME for Warehouse Operations for quality records
- Supports WO / SC projects and Operation Excellence initiatives.
- Interfaces with department Training Leads and ensures compliance for team members in training systems (i.e., Compliance Wire)
- Assesses and provides direction for existing and new business processes; provides SOP updates and enables training to WO staff.
- Ensure development, implementation and maintenance of appropriate training curricula for WO staff
- Supports reporting metrics, and provide information for WO KPIs
- Manage the creation, implementation and compliance for all documentation, procedures and policies
- Efficiently coordinates, communicates, and provides essential Warehouse Operations information and activities status to related functions in a timely manner in accordance to schedules and defined implementation timelines
- Communicate effectively to multi-functional and multi-location teams through team and individual settings
- Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability
- Build a collaborative environment that fosters decisive decision making and accountability
- Build trust and productive relationships with peers and stakeholders
- Deliver business results through timely and quality decision making
- Fosters a culture of high ethics and compliance
- Promote a mindset of continuous improvement, problem-solving and prevention
- Create an environment of teamwork, open communication, and a sense of urgency
- Drive collaboration across the company and external partners
- Develop, maintain and actively manage relationships with support functions, customers and external partners to ensure productivity and collaboration
- Provide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulations
- Work with CAR T Materials Management Organization to build short and long-term capacity models for all warehouse space requirements including controlled room temperature, refrigerated and freezer storage
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.