- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Company’s Commercial organization supports our global sales and marketing efforts around the world.
- Our global sales force continues to solidify the company’s commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific.
- Come join our team and make a meaningful impact on patients’ lives.
- The Quality Assurance manager is responsible for maintaining site quality systems, providing quality oversight of the facility and developing and leading the Quality Assurance organization.
- The company facility Label and Packages drug products and manufactures Formulated Bulk Drug Substance Biological commercial and clinical products.
- It is expected that the incumbent will lead QA Associates in a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- The position requires thorough knowledge and experience with EU & FDA GMP regulations as well as developed managerial, organizational, and project management skills.
- Recruit, develop and lead the QA team in areas of expertise and high performance team behaviors.
- Provide technical expertise and leadership to the QA group with regard Compliance and Quality Systems.
- Oversee the Batch Release process.
- Support Technology Transfers through Process Validation to Regulatory Approval.
- Drive implementation of a science and risk based Quality Culture throughout the facility.
- Lead the preparation and facilitation of Regulatory Inspections.
- Oversee activities rAnchorelated to core quality systems including Deviations, Change Controls and CAPA systems.
- Oversee relevant metrics for each quality system.
M.S. with at least 8 years of experience in a relevant functional area, or a B.S. with at least 10 years experience in a relevant functional area. QP qualification would be an advantage.
- 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
This position will interact with all other departments throughout the organization
Approximately 12 Direct reports
- This description is not intended to be all-inclusive or a limitation of the duties of the position.
- It is intended to describe the general nature of the job that may include other duties as assumed or assigned.