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Director Quality Operations Jobs in Minnesota (NOW HIRING)

Bora Pharmaceuticals

Head of Quality

Maple Grove, MN · On-site

The Director/Sr. Director also directs day-to-day quality operations, drives operational excellence and process optimization, supports execution of strategic and tactical initiatives, and ensures ...

Caerus Corp

Quality Manager

Blaine, MN · On-site

$90K - $130K/yr

This role is responsible for manufacturing and quality operations of Class II medical devices and ... This is a hands-on role requiring direct involvement in CAPA execution, complaint resolution, audit ...

PartsSource

Quality Engineer Technician

Minnetonka, MN · On-site

$18.25 - $24.75/hr

This position combines quality systems oversight with direct operational involvement in product testing, returns management, and quality assurance activities. The Quality Engineer develops and ...

PartsSource

Quality Engineer Technician

Minnetonka, MN · On-site

$18.25 - $24.75/hr

This position combines quality systems oversight with direct operational involvement in product testing, returns management, and quality assurance activities. The Quality Engineer develops and ...

Actalent

Manufacturing Quality Engineer

Minneapolis, MN

$46 - $53/hr

... direct impact on product performance and patient safety. What You'll Do * Serve as the quality ... Partner with engineering and operations teams to ensure compliance with quality system requirements ...

Ametek

Director, Operations

Brooklyn Park, MN

AMETEK MOCON is seeking a Director of Operations to lead manufacturing and supply chain performance ... Ensure safety, quality, delivery, and cost targets are consistently met. * Drive production ...

AMETEK, Inc.

Director, Operations

Brooklyn Park, MN · On-site

$170 - $190/hr

AMETEK MOCON is seeking a Director of Operations to lead manufacturing and supply chain performance ... Ensure safety, quality, delivery, and cost targets are consistently met. Drive production planning ...

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Director Quality Operations information

What are the key skills and qualifications needed to thrive as a director quality operations, and why are they important?

To thrive as a Director of Quality Operations, you need expertise in quality management systems, regulatory compliance, and process improvement, often supported by a relevant degree and extensive experience in quality assurance. Familiarity with tools such as Six Sigma, ISO standards, and quality management software is typically required, along with certifications like ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE). Strong leadership, strategic thinking, and effective communication are vital soft skills for driving cross-functional initiatives and fostering a culture of continuous improvement. These skills ensure that organizational processes meet regulatory standards, reduce risk, and support business objectives.

What are the main challenges a director quality operations typically faces when coordinating cross-functional teams?

Directors of Quality Operations often encounter the challenge of aligning diverse teams—such as manufacturing, regulatory, and R&D—toward shared quality goals. Balancing differing priorities, managing communication across departments, and ensuring consistent adherence to quality standards can be complex. Effective leaders in this role foster collaboration, establish clear processes, and proactively address potential bottlenecks to drive continuous improvement and compliance. Developing strong interpersonal relationships and maintaining transparency are crucial to successfully navigating these challenges.

What does a director quality operations do?

A Director of Quality Operations oversees the quality assurance and control processes within an organization, ensuring that products or services meet established standards. They develop and implement quality management systems, lead compliance initiatives, and coordinate cross-functional teams to improve operational efficiency. This role often involves monitoring regulatory requirements, managing audits, and driving continuous improvement projects. The Director of Quality Operations plays a key leadership role in maintaining customer satisfaction and supporting business objectives.
What are the most commonly searched types of Quality Operations jobs in Minnesota? The most popular types of Quality Operations jobs in Minnesota are:
What are popular job titles related to Director Quality Operations jobs in Minnesota? For Director Quality Operations jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Director Quality Operations jobs in Minnesota look for? The top searched job categories for Director Quality Operations jobs in Minnesota are:
Director Quality Operations jobs near you

Head of Quality

Bora Pharmaceuticals

Maple Grove, MN

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 25 days ago

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary

Reporting to the VP, Regional Head of Quality, the BPI Site Head of Quality is responsible for developing, implementing, and overseeing a comprehensive Quality Management strategy aligned with corporate policies, client expectations, and global regulatory requirements. This role ensures products from development through commercialization are safe, effective, and fully compliant with applicable CGMP/GxP standards. As a key member of the site leadership team, the Director/Sr. Director of Quality provides strategic and operational leadership for the Quality organization, which includes Quality Assurance and Quality Control. The role partners cross-functionally with all departments to foster a strong culture of quality, accountability, collaboration, and continuous improvement while ensuring regulatory compliance and client satisfaction.
The Director/Sr. Director also directs day-to-day quality operations, drives operational excellence and process optimization, supports execution of strategic and tactical initiatives, and ensures timely resolution of quality and compliance issues to maintain business performance and inspection readiness.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Provide strategic leadership and overall accountability for the site Quality Management System (QMS), ensuring compliance with global policies, procedures,CGMP/GxPstandards, and applicable regulatory requirements across the U.S. and international markets.

  • Partner with the Site Leadership Team (SLT) to strengthen and sustain a proactive culture of quality, escalating significant compliance risks and drivingtimely, effective resolution of quality issues.

  • Lead and oversee regulatory inspections and audits, ensuring inspection readiness, effective agency interactions, andtimely, compliant responses to observations.

  • Direct all core Quality functions, including batch record review, material and product disposition, deviations andchange control, document control,QC,QAoversightofallGMPfunctions includingvalidation, quality engineering, and facility activities.

  • Provide leadership to ensure uninterrupted support for successful producttransfersthrough robust quality oversight and operational excellence.

  • Serve as the senior Quality leader supporting development initiativesandphased clinical programs, ensuringappropriatecompliancethroughout product development activities.

  • Lead the Quality organization in achieving operational and strategicobjectives, including budget planning and management, workforce planning, project execution, and organizational effectiveness.

  • Build, mentor, and develop a high-performing Quality organization thatoperatesas a trusted, collaborative business partner, while driving talent development, succession planning, and employee growth.

  • Establish clear, consistent, and effective communication across the Quality organization and with cross-functional stakeholders to ensure alignment on priorities, risks, and businessobjectives.

  • Performadditionalresponsibilities and strategic initiatives as assigned

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience and Skills

  • 10+ years of progressive experience withinGMP-regulated pharmaceutical and/or combination drug-device manufacturing environments.

  • Strong working knowledge of global regulatory requirements and quality standards, including US FDA, EMA, PIC/S, and ICH guidelines.

  • 5+ years of senior leadership experience driving Quality strategy, operational excellence, compliance initiatives, and continuous improvement programs.

  • Proven ability to build and sustain a transparent, collaborative, and quality-focused culture that promotes accountability, engagement, and operational performance.

  • Demonstrated experience leading cross-functional teams and influencing organizational change within complex regulated environments.

  • Prior experience within aCDMOenvironment is strongly preferred.

Other Knowledge,Skillsand Abilities

  • Strong knowledge of pharmaceutical manufacturing operations, including Oral Solid Dose (OSD) processes and associated quality requirements.

  • Demonstrated success in leading organizations through sound decision-making, strategic problem-solving, and effective communication at all levels of the business.

  • Proventrack recordof successfully managing and leading regulatory inspections, audits, and remediation activities with global health authorities.

  • Exceptional written and verbal communication skills, with the ability to influence stakeholders and communicate complex quality and compliance matters clearly and effectively.

  • Proven ability to lead, mentor, and support teams through crisis management, organizational transformation, cultural change, and business growth initiatives.

  • Highly adaptable and resilient, with the ability to perform effectively in fast-paced, high-pressure environments whilemaintainingfocus on priorities and outcomes.

  • Strong leadership capability with a demonstrated ability to empower teams,identifyhigh-potential talent, and drive employee development and succession planning.

  • Results-oriented leader with strong analytical and problem-solving skills focused on continuous improvement and operational excellence.

  • Skilled at building trusted relationships and collaborating effectively with cross-functional peers, senior leadership, clients, and regulatory agencies.

Salary Range: 192,000 - 260,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

  • Competitive salary and performance-based incentives

  • Comprehensive health coverage including medical, dental, and vision insurance

  • Retirement savings plans with employer matching contributions

  • Paid time off

  • Professional development opportunities

  • Employee wellness programs and resources

  • Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

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