Senior Manager, Quality Assurance - Operations
The Senior Manager, Quality Assurance (QA) – Operations is responsible for all activities of the QA Department, including Quality Control (QC), with primary responsibility to ensure compliance with FDA regulations including Current (“c”) Good Manufacturing Practices (“cGMP”), medical device regulations, and New Drug Application (“NDA”) regulations.
The function of the Senior Manager, QA – Operations is to combine knowledge of scientific, regulatory, and business issues to ensure that the company’s products are manufactured and distributed in a manner that meets required FDA (and potentially other international regulatory agencies) legislation at all times. The individual has company level influence and is generally recognized as an expert resource within the company as it relates to all aspects of QA and QC requirements. The individual is expected to share knowledge and to provide guidance and direction, to the organization as a whole in support of all Quality activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Act as the company Quality Management System (QMS) Management Representative and champion activities consistent with company quality objectives and the quality policy.
2. Develop and oversee activities relating to the company’s process and quality improvement programs and initiatives.
3. Provide input, guidance, and/or oversight as needed into the company’s reliability specification, analysis, and testing activities.
4. Oversee and manage collection and periodic distribution of quality metrics that characterize the company’s performance as well as customer satisfaction.
5. In close collaboration with the Manager, QA – Product Development and other key partners, both internal and external to the company, aim to ensure Quality documentation meets regulatory requirements and project target dates.
6. Review all Technical Operations and Manufacturing documentation for regulatory compliance; including validation protocols, close out reports, analytical methods, batch records, Corrective Action, and any other RA-CMC related documentation.
7. Manage the performance and development of staff. Maintain current knowledge of, and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements, and related policies and procedures.
8. Effectively communicate safety and quality issues raised by customers or staff in a timely fashion.
9. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
Ability and willingness to travel up to 20% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in a scientific discipline and 10 or more years of progressive experience in the pharmaceutical or medical device industry, and in quality assurance/compliance; or equivalent combination of education and experience. Five or more years of managerial experience with financial responsibility is required. Experience working directly with regulatory agencies for audits and inspections and sound knowledge of applicable portions of agency guidance and regulations required. Appropriate ASQ certification preferred. Experience with radiopharmaceuticals would be a strong asset in this position and is preferred.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel. Knowledge of electronic QMS & LMS would be valuable, as would experience in selecting and implementing these systems.
Provide an interactive, problem solving environment to address any weaknesses within the team. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Demonstrated strong attention to detail, as well as the ability to work under pressure to meet project deadlines.
• Demonstrated organizational, planning, and prioritizing abilities are required, as well as strong technical writing ability.
• Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
• Able to communicate effectively with employees at all levels of the NorthStar organization as well as with key individuals outside the organization. These outside contacts may include FDA reviewers, consultants, and representatives from clinical sites or other device or pharmaceutical companies.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.