Overview:
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:
This person delivers business-focused, compliant, efficient, and innovative training programs and processes. The scope of this role includes training support including but not limited to, leading the development, delivery, and sustainment of Rocket’s global training program. The Sr Manager of training advises and trains organizational educators (trainers) and content developers on training standards and helps execute the company's training strategy. The Sr Manager of training supports QMS efforts including writing procedures pertaining to overall quality management systems. This position reports to the Director – Quality Assurance QMS.
Responsibilities:
- Responsible for strategy to design, execute, and continuous improvement of companywide GxP training initiatives to align with Rocket’s business needs and health authority requirements.
- Act as a training partner with key stakeholders to help the cross-functional teams develop department specific and job specific training programs.
- Build and oversee training programs and efforts to be in line with initiatives and trends observed to improve overall compliance and business performance.
- Collaborate closely with the GxP Training Manager to develop and ensure timely distribution of all internal training communications for designated departments, training needs identification, and overall training compliance with regards to Rocket’s written procedures.
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Partner with leadership of designated departments and GxP Training manager to ensure employees complete all mandatory training requirements and provide timely status reports.
- Lead and facilitate training sessions conducted with specific agenda and partner with functional teams to ensure effective delivery of such trainings.
- Take a proactive approach to communicating the progress of projects, processes, and tools pertaining to training program management and stakeholders.
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Support tasks associated with quality management systems and electronic QMS application to help write procedures, develop, and conduct training, and help sustain the compliance with written procedures and prevailing regulations.
- Provides and participates in New Employee Orientation covering GxP training, annual GMP refresher training delivery, and support other mandatory annual training as identified.
- Partner with People Operations team to maintain and continually improve the overall employee onboarding experience while using electronic training platform and initial onboarding training.
- Complete other responsibilities, as assigned within Quality Assurance department.
Qualifications:
- Bachelor’s degree, preferably in Life Sciences
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8 to 10 years of work experience covering GxP training programs and QMS within regulated Biopharma industry, working within quality systems.
- Experience with identification, configuration, and implementation of eLMS / electronic QMS system (e.g. Veeva, Compliance Wire etc.) is required.
- Subject Matter Expert on applicable GxP regulations (ICH/FDA/EU) and guidelines pertaining to training needs and requirements.
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Requires excellent prioritization, responsiveness, and customer service, along with excellent verbal communication skills.
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Results-oriented individual who is highly motivated, decisive, flexible, and has the creativity to excel in and contribute to a rapidly growing company with minimal guidance.
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Proven ability to operate in extreme high-pressure situations, successfully handle multiple priorities, and possess a high level of discipline while remaining flexible.
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Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
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Travel requirements up to 10%.
EEO Statement:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.