Manager, Quality Assurance - Product Development
The Manager, Quality Assurance – Product Development (QA-PD) is responsible for developing and maintaining product quality engineering guidance and leadership within new product development. The employee in this role will oversee a group of quality engineers and manage the day-to-day activities associated with quality support for research & development projects and new products. The manager should also coordinate closely with QA – Operations to ensure smooth transition from Product Development to Operations. The manager may serve as the Product Development Core Team Member or assign others within his/her team as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
Develop and maintain internal QA and site systems to meet product development needs while ensuring appropriate adherence to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and other regulatory
Prepare monthly reports for Sr. Quality Management or as requested. Provide appropriate reporting to Senior Management on status of the quality system in relation to product development.
Hire, manage and develop a group of quality engineers.
Contribute to the review, and where appropriate development, of documentation including but not limited to Procedures, Batch Records, Equipment Qualifications Protocols, Analytical Method Validation, and Product Verification/Validation Protocols.
Initiate, review, and approve change
Ensure quality metrics are collected, reviewed, and
Support the resolution of quality issues in product development, through coordination of investigations, submitting and/or initiating change requests, etc.
Contribute to the review of critical analyses of data (post-market surveillance and manufacturing) and independently interpret and develop conclusions; perform reviews of clinical/preclinical/manufacturing protocols, and study
Responsible for organizing data and preparing appropriate documentation for assigned projects in the areas of equipment, software, process, cleaning, control system, and critical system
Coordinate with QA Operations to ensure that development programs and projects can be implemented efficiently and cost effectively within the operational environment.
Effectively communicate safety and quality issues raised by research and development staff in a timely
Support NorthStar’s Quality System and Health & Safety Program by following policies and
Ability and willingness to travel up to 10 % 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 the Physical Sciences and eight or more years of progressive Quality Assurance experience within new product development for the pharmaceutical and/or medical device industry and a minimum of four years of management experience; or equivalent combination of education and experience. Experience working directly with regulatory agencies, sound knowledge of applicable portions of agency guidance, and regulations (21CFR Part 210/211/820 and ISO 13485).
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, Excel, and Power Point.
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.
Excellent communication skills, verbal and written
Strong attention to detail
Ability to work in a team environment, as well as independently
Ability to handle multiple projects simultaneously
Ability to work in a fast-paced environment
Adaptable to change in the work environment
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.