Senior Specialist, Master Data and QMS Process Management
Quality | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene’s Quality organization is building a world class team that is focused on delivering potentially lifesaving therapies to patients. We are seeking a highly motivated individual to join us as Senior Specialist, Master Data and QMS Process Management. You will combine a solid eye for compliance, technical knowledge and innovation to guide process and system enhancements supporting Allogene’s Quality organization. Partnering with business colleagues, you will be accountable for the design and management of our master data processes in support of compliance needs, with the deployment of ERP and other IT systems. Additionally, you will support the development and execution of key Quality Management Systems Processes.
Responsibilities (include but are not limited to):
- Lead the design and implementation of Quality processes as part of our ERP deployment
- Provide expertise in the design and development of end to end processes
- From a Quality perspective, support the ERP Master Data team through design, testing and realization, followed by managing ongoing master data operations
- Execute changes to SAP master data (e.g. customer, vendor, materials, etc.) as approved by the business
- Establish robust master data processes and governance that provide data integrity, accurate and complete master data
- With business counterpart, establish and maintain data definitions, data rules and audit processes for each master data type with metrics for monitoring data accuracy and completeness
- Ensure Master Data Management complies with GMP regulations
- Be the Quality expert for material master, recipes and other master data creation and maintenance
- Actively work with internal customers to reduce master data defects and develop processes that reduce non-value added work
- Support implementation and required cloud based IT system updates for ERP and other systems.
- Ensure data quality, compliance and consistency of master data across IT systems
- Support development, implementation and execution of core quality system processes (e.g. NC/CAPA/change control) and new IT systems (e.g. for NC/CAPA/change control, MES)
- Lead/participate in projects and initiatives across multiple functional areas
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree required
- 8+ years of experience in the biotech/pharma industry
- Experience in Master Data Management and core quality system processes (e.g. CAPA, change control)
- Proven change management and project management leadership and skills
- Demonstrated knowledge of master data processes, data standards and how they relate to the business processes
- Ability to adapt easily to a rapidly changing environment
- Demonstrate ability to influence and foster collaborative relationships with ability to engage resources outside of direct-control to gain consensus, meet deadlines and achieve goals and objectives
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to objectively evaluate options/trade-offs and develop executive management-level recommendation
- Ability to efficiently prioritize work and inform stakeholders on the progress
- Have a compliance, business and technical understanding of ERP systems and Master Data as it relates to manufacturing and supply chain
- Excellent communication skills, both verbal and written in English language, including presentation and influence with all levels of staff, including executives
- Very good interpersonal skills with excellent customer service and “can do “ mentality
- Strong Microsoft Office suite skills
- Experience in full lifecycle ERP implementations and related data migration activities in a pharmaceutical or similarly regulated industry a plus
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.