Senior Manager, Validation
Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.
The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.
We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.
With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.
The Senior Manager, Validation will be a subject matter expert in the Commissioning and Qualification program and provide leadership to manage the site validation of equipment, utilities, computer system and cleaning processes. Responsibilities include manage site validation master plan and deliverables; comply with Novartis Gene Therapies validation standards; manage validation team to support site validation activities; manage and develop a tailored approach for each project they are assigned including assessing vendor validation packages, performing gap analysis to User Requirements, developing plans and protocols using a risk-based approach that complies with company policies and procedures. The role will also be responsible for reporting progress and roadblocks to the project team(s).
- Manage Site Validation Master Plan and deliverables.
- Serve as site subject matter expert to support internal and external inspections.
- Support development of Commissioning and Qualification policies and procedures to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
- Manage site validation activities to support capital projects, and quality and compliance driven initiatives.
- Develop risk-based Validation approach (FMEA, PHA, etc.).
- Manage Computer System Validation.
- Hire and manage commissioning contractors to perform tasks as required.
- Develop project execution plans and manage small to medium size projects.
- Review project documentation (URS, FRS, Technical Specifications, and Functional Specifications).
- Liaise with client end user groups to ensure correct specification of equipment and utilities.
- Perform risk assessments to confirm safe and compliant designs and recommend additional controls as required.
- Author or manage authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices.
- Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information.
- Partner with Quality to ensure a quality and compliant manufacturing environment.
- Manage site periodic review program and ensure a validated state is maintained.
- Bachelor's degree in Engineering, Science or related technical field.
- Excellent technical writing and verbal communication skills.
- Minimum of 8 years of experience in biotechnology GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
- Minimum of 8 years of experience in the design or operation of commercial grade pharmaceutical or biotechnology process equipment and utilities (compressed gas, hoods and cold storage).
- Minimum of 3 years management experience
- Must be people oriented and a team player.
- In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211.
- Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio.
- Experience managing 3rd parties (both in-sourcing and outsourcing).
- Ability to prepare contingency plans and logically work through complex issues in a high-pressure situation.
Approximately 10 - 20% travel required. This position is based in Longmont, Colorado.
The level of this position will be based on the final candidate's qualifications.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.