Senior Systems Analyst, QIT

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Job description

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)- Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center.

About AMEC New Albany, OH: AmplifyBio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a "hoteling model," traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

AmplifyBio is seeking to hire a Senior Systems Analyst, QIT to join our growing team

The Senior Systems Analyst, QIT will be responsible for leading GxP system implementation and providing data integrity and regulatory guidance and oversight throughout the system lifecycle (i.e., plan, implement, run, operate, and retire) at AmplifyBio. Depending on the seniority and experience of the individual, the responsibilities for the role can span from being an individual contributor to a people manager with direct and/or lead matrix teams as assigned.

The Senior Systems Analyst, QIT will report to Quality IT (QIT) Manager for the GMP manufacturing site. This is an on-site role based at our GMP manufacturing site located in New Albany, OH. Being a member of the cross site QIT team, the incumbent will be expected to support other sites as needed.

What You'll Do Here:

• Monitor/maintain/support health, data integrity and regulatory compliance of GxP computerized systems in conformance with all applicable policies and SOPs.
• Develop/own technical SOPs and validation artifacts required to implement and maintain computerized systems.
• Lead/manage computerized system validation activities for new implementations or enhancements to existing systems.
• Perform and author data integrity and GxP risk assessment to ensure effective requirements are captured and controls are in place to meet global regulatory requirements for GxP systems.
• Review/approve/provide inputs to validation artifacts as defined in quality/validation plan and SOPs (collaborate with business owner, system owner and quality owner).
• Participate in/monitor changes to all GxP systems.
• Ensure availability of system inventory and configuration management.
• Facilitate/develop/own/maintain training programs on validation and regulatory requirements of computerized systems.
• Collaborate with various stakeholders (business, quality assurance, internal/managed IT, vendors etc.) to
  • Assess and select computerized system that meets high-level business needs (and may lead technology implementation).
  • Ensure project tailoring is appropriate for the complexity and risk to accommodate full scope of work and validation requirements.
  • Drive resolution to technical issues including audit/inspection related regulatory non-conformance to computerized system (and provide technical support required during audits/inspections).
  • Assure that all systems have quality approved operating level procedures and plans to maintain validated status of GxP computerized systems including health of such systems.
• Provide onsite IT support as needed which may span from simple troubleshooting (e.g. resolving user access issues) to resolve network connectivity issues, setup equipment control computers etc. primarily for the GMP systems working in close collaboration with the IT Operations team.
• Facilitate and lead discussions with vendors to drive problem resolutions or define technical requirements and landscape.
• Benchmark within and outside of the Company, including regulatory agencies, business partners and suppliers.

We Would Love to Hear From You If:

• Minimum BA/BS in a life sciences or engineering/computer science or similar scientific discipline (advanced degree preferred).
• A minimum of 5 years' experience and in-depth knowledge of data integrity requirements and GxP computer system validation, and Part 11 requirements in a Pharmaceutical or Biotech environment including understanding software development and supporting validation IT systems in manufacturing and/or laboratories.
• In depth understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas.
• Proven experience in the interpretation and understanding of cGxPs for the controlled management of paper and electronic records and signatures.
• Cross-functional experience in QC, QA, Validation and Manufacturing is desired.
• Technology skills and experience supporting Linux/Windows OS, cloud infrastructure and basic LAN/WAN architecture.
• Experience with senior leadership level interactions is desired.
• Experience in working in a matrix organization and challenging self and others to continuously learn and improve.
• Consideration will be given to candidates with prior experience and familiarity with similar roles in pre-clinical and manufacturing organizations, such as AmplifyBio.

Desired But Not Required:

• Excellent interpersonal skills, including written and verbal communication.
• Strong sense of urgency, ethics, diplomacy, and discretion.
• Commitment to Quality.
• Excellent team player attitude.
• Ability to demonstrate strong project management skills, gauge urgency and focus on execution of strategic decisions while balancing conflicting priorities.
• Demonstrate strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
• Ability to manage competing priorities.
• Ability to interact effectively with internal and external stakeholders.
• Lean Six Sigma, Project management (PMP), or other applicable professional certifications.
• Open to travel if required.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.

• Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
• Competitive Compensation Package
• We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.
• Generous paid parental leave
• Wellness and Self-Care Programs
• 401(k) match
• Tuition Reimbursement
• EAP/work-life support system
• A fun work environment where everyone's voice matters.
• We are just getting started! More benefits on the way!
• An Opportunity to Change the World

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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