Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a motivated candidate who will be responsible for the development and maintenance of Quality Systems. This is a key role in the continued expansion of Rocket Pharma’s GMP operations, ensuring that our business processes are efficient, effective and compliant. Collaboration, goal-orientation, and an ability to render the complex simple are key success factors for this role.
- Support cGMP manufacturing and laboratory operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
- Responsible for tracking and trending QMS metrics including, but not limited to, those related to training, deviations, CAPA, Change Controls, OOS, and internal/external audits performance.
- Support the maintenance of Rocket Pharma’s electronic Quality Management solution, including workflow facilitation, document migration and configuration management
- Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release.
- Conduct/assist in internal audits and in external supplier/vendor audits against applicable quality system standards and regulations.
- Represent Quality Assurance on project teams and in meetings.
- Support the implementation, continuous improvement and oversight of Quality Management System procedures and associated training material.
Education/Experience and Skills Requirements:
- Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
- 10+ years of relevant GMP experience in pharma/biotech company, working within a quality system
- Well versed in cGMP/ICH/FDA/EU regulations and guidelines
- Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
- Internal and/or external audit experience required, ASQ certification preferred
Desired Competencies: (Edit for job specific preferred qualifications)
- Detail orientation, with strong communication and organizational skills
- Capable of working with minimal supervision
- Demonstrated ability to solve problems
- ASQ or similar certification preferred
Physical/Mental Requirements: (edit for job specific requirements)
- Use of computer with regular requirement to sit, stand and use a keyboard
- Ability to uphold the stress of travel
Travel Requirements: 20% travel may be required
Relocation Available: No
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.
About Rocket Pharma
Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. www.rocketpharma.com.
Interested in joining our team? Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org