Associate Director, Data Systems & Controls
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
As part of the Astellas Gene Therapy (AGT) Research & Technical Operations (RTO) Engineering & Facilities team, the Associate Director, Data Systems & Controls is responsible for providing overall management (strategy, planning, coordination, execution, support) of Information Technology systems, applications, hardware, and software in use at our gene therapy lab and non clinical production facilities, with a focus on performance, stability, security, compliance, and data integrity. Oversees automation platform advancements and enhancements in collaboration with Digital Analytics & Technologies and Research Quality Assurance team members. Manages document integrity and control advancements and sustaining support to the RTO division. The AD, Data Systems & Controls is a strategic and tactical leader, providing guidance and oversight to both direct performance and third-party services in support of these expectations. Partners with business areas to identify system requirements and translates business requirements into functional service projects, enhancements, and support.
Responsibilities:
Manages and supervises the activities of the team, providing mentorship, coaching, development, and reinforcing objective accountability while promoting and fostering a culture of innovation, collaboration and engagement.
Advance IT, data integrity, and documentation control leadership through alignment with, and reinforcement of, industry best practices while driving continuous improvement initiatives or solutions to systemic gaps and challenges.
System ownership of RTO IT and lab informatic systems and applications, and performance of computer system validation and system administration in accordance with defined procedures, and ready to present to regulatory inspectors and internal auditors during inspections and internal/partner audits.
Drives or supports the delivery of capital projects in accordance with the project and asset lifecycle and project management playbook, with visibility via dashboards, status reports, & meeting minutes.
Tracks and monitors demand, including budget and resource planning. Works with project controls and finance team members on periodic budget updates, accruals, and forecasts.
Coordinates and collaborates with Digital Analytics & Technologies in support of related demand planning and cross team project support to meet agreed scope and deliverables as well as aligning cross division systemic opportunities, business case development, and project prioritization efforts.
Establishes data management, data integrity, and business continuity strategic plans.
Chairs RTO IT Committee focused on promoting collaborations, metrics reviews, and continuous improvements.
Responsible for authoring and reviewing GxP/Non-GxP documentation including functional specifications, design specifications, network diagrams, change control, computer validation testing, inspection readiness, disaster recovery, and departmental support processes and procedures.
Executes change control processes for deployment of system/database software across GxP validated environments.
Oversees contractors and consultants engaged in the design, implementation, modifications, and testing of IT systems, ensuring contracting, training, and vendor qualification processes are adhered.
Integrates new equipment into systems while ensuring compliance.
Executes testing and installation of system/database patches, upgrades, and new releases.
Develops policies and procedures, and oversees continuous improvement of knowledge management, audit trail reviews, code management, and systems administrations and backup.
Provides guidance and assistance to resolve issues/conflicts and provide mentoring and guidance to team members.
Defines appropriate standards, policies, procedures, software toolsets, and supporting peripherals to facilitate the management, accountability, compliance, and functionality of system/databases and applications.
This position is a technical and team leadership position reporting to the head of RTO Engineering & Facilities within the Astellas Gene Therapies Research & Technical Operations Division.
Required:
BA/BS or equivalent in engineering, information systems or equivalent focus of study typically having 10+ years relevant experience with a minimum of 7+ years related IT and management experience
Proven experience with Hosted, SaaS, On-Prem applications support GxP application in a Biotechnology research environment.
Demonstrated leadership, critical thinking skills, and ability to influence across the organization to achieve milestones
Expertise in regulatory compliance with respect to computer system validation and change control
Strong problem-solving, decision-making skills, interpersonal skills and ability to work in a team
Strong understanding of network connectivity and troubleshooting related application issues in a manufacturing environment
Excellent technical writing, verbal communication and time management skills
Proven experience with managing resources deployed supporting virtualized infrastructure for manufacturing and process control.
Excellent project management skills and substantial exposure to project-based workload and breakdown structures, software development cycles
Some travel will be required
Models our Core Values: Be Bold, Find a Way, Care Deeply, Get Stuff Done – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
Preferred:
Experience with systems including PI, BMRAM, A-Note, & Benchling, a plus
Experience working with quality controls in a research gene therapy facility
Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet production deadlines
Ability to deal with ambiguity, creative and pragmatic approach to problem solving
Exposure of regulatory authority inspections and inspection readiness
Working Conditions:
- This position will be hybrid, with onsite work required at least 3 days per week and will require less than 10% travel.
Salary Range:
- $153,000 - $204,000 (NOTE: Final salary could be more or less, based on experience)
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability
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Category GT - Engineering & Facilities
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans