Senior Manager QA

Found in: beBee S IE - 4 weeks ago

Ireland Regeneron Pharmaceuticals, Inc Full time

Within this role you will be responsible for the management and oversight of the QA Operations, Document Control (DC) function. This role will be part of the QA Operations site management team. This role includes oversight of the following areas: Document workflows, Records Issuance, Information & Records Management, Technology, Inspection Readiness & Support, Continual Improvement, Projects, Planning, Logistics and Metrics. Ensures partnerships are built and maintained with areas DC supports to drive high quality throughput via efficient and effective processes.

As a Senior Manager QA, a typical day might include, but is not limited to, the following:

  • Ensuring timely prioritization of work and projects
  • Providing coaching and guidance to employees for performance and development
  • Supporting global communication and visibility with managers through practices such as huddles and management team meetings
  • Directing and continuously improving Doc Control processes ensuring that performance and quality conform to regulatory standards and internal requirements
  • Driving initiatives supporting departmental growth and organizational objectives to improve processes, reduce waste and improve efficiency
  • Providing leadership and collaboration within and across the organization at all levels, across functional groups
  • Ensuring global alignment of processes, systems and procedures, unified communication to user areas, and identification of system enhancements
  • Initiating and sustaining communication with business areas to help the business understand DC processes and to improve the overall efficiency and effectives of our systems
  • Collaborating with the respective customer and department management within their sphere of influence to develop and support department and customer initiatives
  • Identifying risks to operations and collaboratively works with team and business to identify and implement mitigations
  • Providing on the floor guidance to the team and business areas for inspection readiness and fosters the Regeneron Way and IOPS culture of safety, cleanliness, and compliance
  • Developing personnel, supports a positive, diverse, equal, and inclusive work environment and builds a high-performing team
  • Ensuring appropriate resourcing for document schedule planning adherence
  • Developing resourcing strategies to plan and manage the operating budget and headcount budget and forecast to ensure maximum utilization of personnel to fulfill department objectives
  • Managing relationships with external departments to understand feeders that will impact resource usage and needs and proactively identify and mitigate issues
  • Defining and implementing quality standards, systems, and metrics for DC to ensure performance, compliance, effectiveness, efficiency, and value to the business in line with department goals
  • Overseeing area relevant improvement projects driven by the business priorities (global and local)
  • Creating pathways for communication of key information to business areas, ensuring accurate data is visible and usable
  • Serving as Business Process Owner of area owned systems
  • Reporting status of process performance and ensures on-time and accurate metrics for presentation
  • Supporting DC global teams, projects, and initiatives; continuously partnering with counterpart site leads
  • Supporting business driven Global/cross-site improvement projects
  • Working with department management to maintain a robust inspection readiness program, foster an inspection ready mindset and ensure documentation generation and maintenance all supporting successful inspections
  • Involving in Regulatory Agency interactions and preparing as related to site inspections and ensuring regulatory observations in their area are adequately addressed and completed on schedule

This role might be for you if:

  • You have working knowledge and technical experience in a Document Control/Information and Records Management operations and/ or experience in Quality Systems operations
  • You are comfortable making decisions independently with demonstration of good judgment in escalating issues to management and QA colleagues
  • You demonstrate an ability to negotiate, influence and lead with and without direct line authority
  • You are skilled in analyzing information of considerable difficulty and drawing valid conclusions
  • You Demonstrate leadership skills and strong interpersonal skills
  • You have high-energy in a fast paced environment with changing priorities

To be considered for this opportunity you should have a Requires BA/BS degree and at least 8 years of experience or equivalent combination of education and experience in a pharmaceutical/biologics manufacturing environment. Previous people management and/or team leadership experience required

#IRELIM #JOBSIEPR #REGNIEQA #LI-Onsite

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. #J-18808-Ljbffr

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