Location: Buena, NJ
The Stability Testing Manager is responsible for managing the stability testing for both commercial and pre-approval. This person will supervise the commercial and pre-approval stability supervisors. The Manager will also provide the leadership necessary to support the business needs of the site and achieve outstanding product quality. These activities include the establishment, implementation, maintenance, and improvement of select Quality procedures and processes.
Reporting Relationships: 3-5 direct reports
- Manage routine operations and oversee scheduling commercial and pre-approval stability testing.
- Provide ongoing quality control support to all departments as required. Actively participate in launch meetings and provide timely communication to internal and external customers.
- Actively participate in pre-approval project meetings to coordinate ANDA submission activities and FDA responses required for the respective pipeline projects.
- Ensure that laboratory investigations associated with commercial and pre-approval stability are reviewed and approved in a timely manner.
- Develop standards and maintain quality metrics for commercial and pre-approval stability testing.
- Review approve and train on new and revised quality documents (specifications, analytical test methods, SOPs, protocols, technical documents, etc.) in support of product testing and continued improvement to the Quality System.
- Support new product development through timely testing of exhibit batches and stability. Prepare COAs and other documents, as required, for regulatory submissions.
- Keep upper management informed of all key quality findings and issues.
- Use all electronic systems as needed within the department.
- Assumes other activities and responsibilities from time to time as directed.
- Provide leadership for quality operations, to implement clear policies, processes, and metrics in line with business strategy and regulatory requirements that drive consistency and compliance with quality standards.
- Develop a highly engaged, self-empowered and capable team through goal setting, mentoring, talent development activities, and reviews.
- Supporting the non-conforming material system including: ensuring compliance to procedures; performing root cause analyses; performing trend analyses; developing and implementing corrective actions; improving procedural efficiencies.
- Performing product, data, and trend analyses to support organizational needs and continuous improvement activities.
- Drive continuous improvement objectives and initiatives. Leads or participates in quality improvement projects.
- Other duties as assigned.
- Bachelor’s Degree in a related science field.
- Minimum 5 years of progressively responsible management of quality issues in a pharmaceutical environment.
- Demonstrated knowledge of GMP requirements
- Strong interpersonal and organizational skills, ability to work with minimum direction.
- Excellent verbal and communication skills.
- 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.