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Quality Validation Manager Jobs in Indiana (NOW HIRING)

INCOG

Senior QA Validation Specialist

Fishers, IN

$77K - $106K/yr

The Senior Quality Validation Specialist provides Quality Assurance oversight of validation ... Working knowledge of equipment and system life cycle management, including URS development, risk ...

BlackDiamond Networks

CQV Lead

Indianapolis, IN · On-site

... managing schedules, supporting FATs, overseeing qualification execution, and ensuring successful ... Validation, Quality, and Operational Readiness teams throughout the project lifecycle. Key ...

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Quality Validation Manager information

What is the difference between Quality Validation Manager vs Quality Assurance Specialist?

AspectQuality Validation ManagerQuality Assurance Specialist
CertificationsISO 9001, Six Sigma, CQEISO 9001, Six Sigma, CQE
Work EnvironmentManufacturing, pharmaceuticals, tech companiesManufacturing, healthcare, software development
ResponsibilitiesOversees validation processes, ensures compliance, manages validation teamsPerforms audits, develops QA procedures, monitors quality metrics

The main difference is that a Quality Validation Manager focuses on validating processes and systems to ensure compliance, often managing validation teams, while a Quality Assurance Specialist concentrates on implementing QA procedures, conducting audits, and maintaining quality standards. Both roles require similar certifications and are vital in industries like manufacturing and healthcare, but their core responsibilities differ in scope and focus.

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Quality Validation Manager jobs near you
Manager, QA Validation Oversight

Manager, QA Validation Oversight

Regeneron Pharmaceuticals

Rensselaer, IN • On-site

$90K - $173K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 28 days ago

Regeneron rating

8.7

Company rating: 8.7 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

13th of 71 rated pharmaceutical

Job description

Regeneron is hiring a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.

In this role, a typical day might include the following:

  • Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.

  • Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.

  • Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.

  • Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.

  • Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.

  • Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.

This role might be a for you if you:

  • Bring hands-on validation experience in a GMP-regulated environment.

  • Possess deep understanding and expertise in Process Validation.

  • Enjoy building strong, collaborative relationships across global internal teams.

  • Have a continuous improvement mindset.

  • Are an experienced leader who inspires and guides a multi-tiered team.

To be considered for this role, you must hold a Bachelor's degree in Engineering, Chemistry, or Life Sciences degree and the following minimum years of experience for each level:

  • Associate Manager: 6+ years

  • Manager: 7+ years

May substitute relevant experience in lieu of education requirement. Level is determined on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.


Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.


As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.


For jobs in Canada: this posting is for an existing position.


Salary Range (annually)

$90,800.00 - $173,400.00

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