We are currently looking to fill a Manager, Quality Assurance position. This position will support a new internal aseptic drug product filling facility consisting of formulated drug substance, filling, device assembly, packaging and labeling. The Quality Assurance Manager will provide the leadership, direction, and the overall Quality for the Visual Inspection, Assembly, Pack and Label areas. The position will be responsible for the visual inspection, assembly and pack and label Shop Floor Quality and Batch Record/MES Review team during second shift. Responsible for ensuring the supported areas meet current company procedures, FDA and International Regulatory Body requirements.
Available Work Schedules:
In this role, a typical day might include the following:
Quality Assurance Shop Floor Support for Facility Start Up Activities including but not limited to:
Equipment Design and SAT assistance for Visual Inspection, Device Assembly and Pack and Label
Program Development for Label Control and Issuance
Quality Risk Assessments
SOP creation and editing
Batch Record Program Development, including batch record creation and revision
May also support the filling areas
Responsible for QA Visual Inspection, Assembly, Pack and Label second shift team that performs routine tasks, such as: Line clearance, Line Inspection, AQL sampling, Batch record review and approval
Performs line clearance checks, and quality-on-the-shop-floor responsibilities of first response to product quality issues in production
Reports metrics weekly, monthly, KPI, Quality Council
Places product, facility, and equipment holds
Oversight of the Visual Inspection, Assembly, Pack and Label quality staff training
Performance of periodic formal and informal audits are completed in production, publishing audit walkthrough observations
Provide first response for Quality and Compliance issues on the manufacturing floor and lead triage activities for events
Drives projects through completion within timeline, quality, and budgetary constraints
Interacts with senior management to report on project and program updates and to present project needs
Interacts closely with Quality Systems, Manufacturing, Process Science, Manufacturing Science & Technology, Supply Chain, and Lab Management to ensure unfavorable trends are identified and resolved
This role may be for you if you:
Are able to pass a visual acuity exam according to SOP requirements
Have knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products
Are experienced using and / or developing qualification kits and qualifying operators
Possess proven strong interpersonal, cross- cultural, communication, negotiation and problem-solving skills
Exhibit confidence, has a high emotional IQ, and demonstrated ingenuity, creativity and resourcefulness
Understand and listen to team members and stakeholders needs while supporting a positive team environment
Have 2+ years of experience leading and developing a team.
To be considered for this role you must hold a BA / BS degree in a physical or biological science the following minimum amounts of relevant experience for each level:
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$86,900.00 - $194,200.00