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Associate Quality Compliance Jobs in Indiana (NOW HIRING)

Actalent

QA Associate

Clinton, IN

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Provide day-to-day quality support for production areas to help ensure compliant manufacturing ... Bachelor's or Associate's degree in a related field, or no degree with at least 12 months of QA or ...

INCOG BioPharma Services

QA Associate

Fishers, IN · On-site

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and ...

INCOG

QA Associate

Fishers, IN

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and ...

INCOG BioPharma Services

QA Associate

Fishers, IN · On-site

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and ...

INCOG BioPharma Services

QA Associate

Fishers, IN · On-site

Description Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in ...

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Associate Quality Compliance information

What is an associate quality compliance?

An Associate Quality Compliance is a professional who helps ensure that a company’s products, processes, and operations meet regulatory and quality standards. They assist in monitoring compliance with industry regulations, conducting audits, reviewing documentation, and supporting the implementation of quality management systems. This role is often found in industries such as pharmaceuticals, medical devices, food production, and manufacturing, where maintaining high standards is critical. Associate Quality Compliance professionals work closely with other departments to identify areas of improvement and help resolve quality issues.

What are the key skills and qualifications needed to thrive as an associate quality compliance?

To thrive as an Associate Quality Compliance, you need a solid understanding of quality assurance principles, regulatory standards (such as ISO or GMP), and a relevant bachelor’s degree, often in life sciences or engineering. Familiarity with compliance management systems, audit tools, and documentation software is typically required, along with knowledge of industry-specific certifications. Strong attention to detail, analytical thinking, and effective communication are crucial soft skills for this role. These skills ensure accurate compliance processes, mitigate risks, and support organizational adherence to regulatory requirements.

How does an associate quality compliance professional typically collaborate with other departments to ensure regulatory standards are met?

As an Associate Quality Compliance professional, you’ll regularly interact with teams such as manufacturing, research and development, and quality assurance to ensure all products and processes meet regulatory requirements. This collaboration often involves reviewing documentation, coordinating audits, and providing compliance training to other departments. You'll also help resolve non-conformities and support continuous improvement initiatives, making strong communication and teamwork skills essential for success in this role.

What is the difference between Associate Quality Compliance vs Quality Assurance Specialist?

AspectAssociate Quality ComplianceQuality Assurance Specialist
CertificationsISO, GMP, HACCPISO, GMP, HACCP
Work EnvironmentManufacturing, Healthcare, PharmaceuticalsManufacturing, Software, Healthcare
Employer & Industry UsageRegulated industries requiring complianceQuality process improvement across industries

Both roles focus on quality but differ in scope. Associate Quality Compliance primarily ensures adherence to regulations and standards, often supporting compliance documentation and audits. Quality Assurance Specialists focus on testing, process validation, and improving quality systems. While overlapping in certifications and industry settings, compliance roles emphasize regulatory adherence, whereas QA specialists concentrate on product quality and process improvements.

What are the most commonly searched types of Quality Compliance jobs in Indiana?

The most popular types of Quality Compliance jobs in Indiana are:

What cities in Indiana are hiring for Associate Quality Compliance jobs?

Cities in Indiana with the most Associate Quality Compliance job openings:

Associate Quality Compliance jobs near you

Head of QA Operations (Assoc Dir level)

Novartis

Indianapolis, IN • On-site

$138K - $257K/yr

Full-time

Medical, Retirement, PTO

Posted 28 days ago

Novartis rating

7.5

Company rating: 7.5 out of 10

Based on 17 frontline employees who took The Breakroom Quiz

64th of 86 rated pharmaceutical

Job description

Job Description Summary

Location: Indianapolis, Indiana
Make a meaningful impact at the forefront of advanced cancer care. As Head of QA Operations, you will lead the Quality Assurance Operations organization supporting Novartis' Indianapolis Radioligand Therapy (RLT) Drug Product manufacturing site, providing quality oversight for production, quality control operations, and product disposition activities. This is a highly visible leadership opportunity to build and develop high-performing teams, strengthen quality culture, and partner across manufacturing, quality control, engineering, and site leadership to ensure the reliable delivery of innovative therapies to patients who need them most. If you are passionate about operational excellence, regulatory compliance, and developing people while driving continuous improvement, this role offers the opportunity to make a lasting difference every day.


Job Description

Key Responsibilities

  • Lead the QA Operations organization, providing quality oversight for Drug Product (DP) Manufacturing and Quality Control operations, including Shop Floor QA, QA Engineering, and final product disposition.

  • Ensure compliant andtimelyproduct disposition decisions whilemaintainingpatient safety and regulatory compliance.

  • Drive quality oversight across manufacturing operations, promotinginspectionreadiness and operational excellence.

  • Lead resource allocation, capacity planning, and operational prioritization to support quality, compliance, and businessobjectives.

  • Lead investigations, deviations, corrective actions, and change controls to resolve quality issues effectively.

  • Ensure preparation, review, and delivery of validation plans supporting compliant manufacturing and quality operations.

  • Support escalation management, FDA interactions, and commercial product field actions whilemaintaininginspectionreadiness.

  • Build, coach, and develop high-performing leaders and teams while strengthening site quality culture.

  • Partner cross-functionallyto achieve production goals, address risks, and support business priorities.

  • Monitor quality performance metrics and drive continuous improvement initiatives to strengthen compliance and execution.

Essential Requirements

  • Bachelor of Science in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience.

  • 10+ years of experience in Quality Assurance, Quality Control, Quality Systems, Compliance, or operationalGxParea(Manufacturing / Development) within the pharmaceutical, diagnostic, or medical device industries.

  • Prior experience leading a Quality Assurance organization, including developing high-performing teams and talent.

  • Prior experience supporting aseptic pharmaceutical manufacturing operations.

  • In-depth knowledge of current GMPs, Quality Assurance, Quality Control, and applicable regulatory requirements and standards.

  • Direct experience conducting investigations and root cause analysis for pharmaceutical or medical device products.

  • Experience reviewing manufacturing and Quality Control validation documents and supporting validation activities in a regulated environment.

  • Proven experience leading Health Authority inspections and audits within a regulated manufacturing environment.

Desirable Requirements

  • Experienceinadvancedtherapy platforms, including Radioligand Therapy, Cell and Gene Therapy, or other novel therapeutic technologies.

  • Experience with continuous improvement methodologies such as Lean, Six Sigma, or 5S and leadingprojects.

The salary for this position is expected to range between $138,600and $257,400per year.The final salary offered isdeterminedbased on factors like, but not limited to, relevant skills andexperience, and upon joiningNovartiswill be reviewed periodically. Novartis may change the publishedsalary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the

role, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health,lifeanddisability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Inaddition, employees are eligible for a generous time off package including vacation, personal days,holidaysand other leaves.

To learn more about the culture, rewards and benefits we offer our people clickhere.

#LI-Onsite


EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.


Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Salary Range

$138,600.00 - $257,400.00


Skills Desired

Collaboration, Data Integrity, Decision Making, Leadership

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