Open Positions: Manager, GxP Documentation and Training
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.
The Manager, GxP Documentation & Training is responsible for executing the requirements of the Arvinas Quality Systems as they pertain to the management of GxP-related documentation; management of GLP samples; and administration of the GxP training program.
This position provides support to the various GxP functions within Arvinas in facilitating the development, review, approval and issuance of Quality System Policies and Procedures and provides technical and administrative support for electronic document management system (EDMS) users. The position also has direct responsibility for the administration of the GxP training program through the electronic learning management system, including management of training curricula and reporting on training compliance.
The incumbent works directly with the Arvinas Quality team and members of the various GxP functional groups to ensure effective execution of the Arvinas Quality System requirements and compliance with the applicable GMP regulations / guidelines and industry standards regarding documentation management, GLP sample management, and GxP training administration.
The position also contributes to the development, performance monitoring and continuous improvement initiatives related to the company’s Quality Systems and their associated processes, policies, and procedures.
This position reports to the Senior Director, Quality Assurance and will be based out of our headquarters in New Haven, CT or may be performed remotely from a location within in the U.S.
Key responsibilities of this role include, but are not limited to:
- Overall responsibility for Quality Assurance administration of the Arvinas EDMS (Veeva Vault - QualityDocs), including:
- Ensures the EDMS is maintained in compliance with the Arvinas Documentation Quality System requirements and procedures.
- Develops and maintains standard operating procedures, work practices and user guides related to the management and use of the EDMS. Develops training materials and provides training to EDMS users as required to ensure proper use of the system; provides user trouble-shooting support as needed.
- As needed, assists users in facilitation of the document lifecycle (drafting, review, approval and issuance) for Arvinas Quality Policies and Procedures using the EDMS.
- Continually explores opportunities to optimize / improve the document management processes and procedures. Actively manages use of the EDMS to identify and implement changes that enhance cGMP compliance (e.g., ease of document retrieval, data integrity) and user efficiency.
- Collaborates with Information Technology to evaluate and implement EDMS changes / improvements.
- Fulfills GxP documentation requests from internal functional groups, business partners and regulatory agencies, as appropriate.
- Overall responsibility for Quality Assurance administration of the Arvinas GxP Training Program, including:
- Ensures the GxP Training Program is maintained in compliance with the Arvinas Training Quality System requirements and procedures.
- Develops and maintains standard operating procedures, work practices and user guides related to the management and use of the electronic training / learning management system (Veeva Vault Quality).
- Develops training materials and provides training to users as required to ensure proper use of the system. Also provides user trouble-shooting support as needed.
- Maintains training curricula for users and ensures curricula are current; develops and issues management reports related to on-time training performance.
- Continually explores opportunities to optimize / improve the training management processes and procedures. Actively manages use of the LMS to identify and implement changes that enhance cGMP compliance and user efficiency.
- Collaborates with Information Technology to evaluate and implement LMS changes / improvements.
- Manages GLP sample storage through a contract sample storage provider, including maintenance of sample inventories sample destruction in accordance with regulatory and Arvinas procedural requirements.
- B.S. or Associates degree in a relevant discipline.
- Minimum of 5 years of pharmaceutical quality assurance experience in support of GxP documentation and management and the administration of GxP training programs.
- Hands-on experience and expertise in the use administration of Veeva Vault Quality electronic document management and training systems; Veeva Vault Quality administrator certification a plus.
- Working knowledge in the application of the US GMP regulations as related to documentation management, GLP sample management and GxP training administration.
- Strong communication skills (verbal / written).
- Ability to effectively provide Veeva Vault Quality training and guidance to system users.
- Ability to prepare standard operating procedures, work practices and user guides related to the administration of the document management and training Quality System requirements.
- Oral and written presentation skills to address colleagues at all levels of the organization, e.g., development and delivery of training presentations; development and presentation of periodic management reports on training performance.
- Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.