Location: Buena, NJ
The primary responsibility of this role is to oversee the Quality function at the Buena NJ site that is engaged in the manufacturing of sterile injectables and topical products.
- Act as site lead for Buena Quality function that manufactures a range of products, with a focus on sterile injectables and topical products.
- Ensure the implementation of uniform quality systems.
- Prepare and present the Quality report to executive management.
- Provide support for major regulatory audits and interact with regulatory agencies as needed.
- Coordinate with Production and R&D functions and support on quality related matters.
- Plan for GMP audits for existing facilities.
- Experience with multiple regulatory agencies (FDA, EMEA, MHRA, etc.)
- Implement Quality improvement plans through cross functional processes between Quality units, R&D, Manufacturing, and Regulatory Affairs.
- Provide input to Regulatory Affairs and R&D on product quality by design.
- Devise, review, implement and manage systems within the group, including communication and information management, to achieve continuous process improvement.
- Minimum Experience: 15+ years of demonstrated success in quality; preferably in a leadership capacity
- Minimum B.S. degree in a technical or science discipline (e.g., chemistry, biology, engineering); advanced degree in a related field is desirable
- Strong Quality leadership background ideally including experience with sterile injectables
- Experience with starting up a new manufacturing site and/or new manufacturing line.
- Strong emotional intelligence, integrity, humility, perseverance, a sense of urgency, and the motivation/desire to join a fast-growing company, and to shape a newly-created role
- Able to manage priorities, think intuitively, and problem solve
- Able to set long-term goals and drive cross-functional teams to achieve expectations
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs