Senior IT Quality & Systems Validation Engineer
- Vision , Medical , Dental , Retirement
- Full-Time
About SpringWorks Therapeutics:
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.
SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.
SpringWorks Leadership Principles:
- Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
- Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
- Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
- Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment
Job Summary:
The Senior IT Quality & Systems Validation Engineer will ensure that IT projects, processes, and services are delivered with the appropriate level of documentation, quality, and compliance with SpringWorks and regulatory expectations (for example Annex 11, 21 CFR Part 11, and CSA) by providing best practices, Quality Management, and Computerized System Validation (CSV) expertise, guidance, and oversight for regulated systems in their domain coordinating with ITS partners and business stakeholders.
Key Responsibilities:
- Contributes to the evolution of the ITS Quality Management System.
- Ensures compliance of the development, delivery, and maintenance of Business IT Solutions
- Provide training, guidance, and adequate support regarding applicable regulatory (e.g. GxP, SOX) and internal requirements for the design and implementation of computerized systems, the application of project methodology and validation/qualification process.
- Define validation/qualification strategy and provide advice, guidance, and performing validation activities in collaboration with SpringWorks Quality Assurance (QA) and Project teams following a risk-based approach.
- Provide guidance and oversight for the management of CAPA's related to the supported computerized systems.
- Supports IT Risk Management through identification, classification, and development of mitigation plans, in collaboration with the IT Team and other stakeholders.
- Contributes to the development and continuous improvement of the IT Quality System, SOX Controls, Computerized System Validation, IT Lifecycle and other IT Processes.
- Promotes quality and compliance throughout the system life cycle and plan for awareness and training on Q&C topics, including Quality Management System, Computer System Validation and SOX Controls.
- Supports the IT and SpringWorks Quality during audits and inspections.
- Collaborates with Business System owners, SpringWorks Quality and Solution Center representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management System (QMS)
- Provides expertise and train staff on proper audit processes and behaviors.
- Supports internal quality assessments and reviews for assigned projects and applications to ensure compliance and / or application of best practices
- Supports annual Sarbanes-Oxley Audits by assisting with preparation, evidence collection and testing, and coordinating with auditors
- Participates on external vendor audit teams, upon request
- Participates in the onboarding and assessment of new technologies
- Performs other duties and responsibilities as assigned
Qualifications:
- Education: Bachelor's degree in business/technical area or equivalent work experience
- 5+ years' experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment including authoring and/or execution of lifecycle documents including plans, protocols, reports, traceability matrices, and risk assessments
- Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP).
- Must have strong hands-on, end-to-end CSV project experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management.
- Solid understanding of data integrity risks.
- Ability to manage complex technology projects and timelines in a matrix team environment.
- Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
- Ability to travel occasionally including overnight stay driven by business need.
- This position must be able to work East Coast hours. #LI-Remote
Compensation:
The expected salary range for this position is $105,000 – $137,000. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.
At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.
This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.
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