Senior Director of Quality Operations

Medline Industries, Inc.; Northfield (MN); On-site; USD 203,000 - 305,000; Full time

Job summary

Medline Industries, LP is seeking an executive leader to oversee strategic planning for large, complex Quality teams across pharmaceutical sites, ensuring cGMP compliance and optimal product quality.

Responsibilities include directing QA programs, regulatory readiness, risk management, CAPA, and collaboration with Operations, Supply Chain, and Business Leadership to meet quality objectives and customer satisfaction.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field is typically required.
• 8+ years of experience in pharmaceutical manufacturing with GMP/QSR/ISO compliance.
• 5+ years of management experience in a relevant field.
• Proven track record leading enterprise-wide validation, quality, or technical operations programs.

Responsibilities

• Provide strategic Quality oversight of manufacturing, packaging, testing, and laboratory operations across Medline pharmaceutical sites to ensure cGMP compliance.
• Ensure appropriate product disposition decisions through evaluation of manufacturing, laboratory, and quality data.
• Drive Operational Excellence initiatives focused on quality, compliance, efficiency, and continuous improvement.
• Build partnerships with Operations, Supply Chain, Technical Services, and Business Leadership to meet quality and business objectives.
• Ensure site readiness for regulatory inspections, customer audits, and internal assessments.
• Provide leadership for quality risk management, deviation management, investigations, CAPA execution, and escalation processes.
• Drive a culture of accountability, compliance, and continuous improvement across all pharmaceutical manufacturing operations.
• Provide leadership and expertise in strategy development for applicable organizations; motivate teams and ensure execution.
• Assist Suppliers, manufacturing partners and product managers in QA program development and implementation.
• Advise leadership to ensure QSR compliance across departments as measured by FDA/ISO/internal audits.
• Act as liaison with Executive Leadership of Divisions, Suppliers, Manufacturing, and Operations for quality products and on-time delivery.

Skills

Quality leadership

Pharma manufacturing

QA leadership

Regulatory inspections

Leadership

Regulatory knowledge

Data analysis

Excel

Travel willingness

Education

Bachelor’s degree in Engineering, Science, or Technical Field

Job description

Job Summary

Responsible for overseeing and directing strategic planning for large and highly complex Quality teams; ensuring quality and compliance for applicable products and processes for assigned departments.

Job Description

MAJOR RESPONSIBILITIES

• Provide strategic Quality oversight of manufacturing, packaging, testing, and laboratory operations across Medline pharmaceutical sites to ensure compliance with cGMP requirements and internal procedures.

• Ensure appropriate product disposition decisions through effective evaluation of manufacturing, laboratory, and quality data.

• Drive Operational Excellence initiatives focused on quality, compliance, efficiency, and continuous improvement.

• Build and maintain strong partnerships with Operations, Supply Chain, Technical Services, and Business Leadership to achieve quality and business objectives.

• Ensure site readiness for regulatory inspections, customer audits, and internal assessments.

• Provide leadership and oversight for quality risk management, deviation management, investigations, CAPA execution, and escalation processes.

• Drive a culture of accountability, compliance, and continuous improvement across all pharmaceutical manufacturing operations.

• Provide leadership and expertise in the development of strategy for the applicable organizations; motivate and engage others around team vision and manage others to ensure execution.

• Provide assistance, support and expertise to Suppliers, manufacturing partners and product manager developing and implementing QA programs.

• Advises leadership to ensure the QSR for assigned departments are in compliance as measured by FDA/ISO/internal audits.

• Act as liaison with Executive Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.

Management responsibilities include:

• Typically, manage through multiple Managers. Provide leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability.

• Strategic, tactical and operational planning (12 + months) for the function or department;

• Direct budgetary responsibility for one or more departments, functions or major projects/programs;

• Interpret and execute policies for departments/projects and develops;

• Recommend and implement new policies or modifications to existing policies;

• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

MINIMUM JOB REQUIREMENTS

Education

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.

Work Experience

• At least 8 years of experience related to the manufacture of pharmaceuticals including GMP, risk management, and working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR11/12, PIC/S, ICH, and other relevant guidance). Some Medical Devices Experience also preferred.

• At least 5 years of management experience.

Knowledge / Skills / Abilities

• Proven experience leading enterprise-wide validation, quality, or technical operations programs.

• Extensive experience supporting high-volume pharmaceutical manufacturing operations.

• Extensive experience leading pharmaceutical quality control and quality assurance organizations, including laboratory operations.

• Significant experience supporting FDA and global regulatory inspections, including inspection readiness and regulatory response activities.

• Demonstrated ability to make risk-based decisions that appropriately balance compliance, supply continuity, patient safety, and business objectives across multiple manufacturing sites.

• Strong leadership, organizational development, and stakeholder management capabilities.

• Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)

• Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.

• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.

• Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).

• Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

PREFERRED JOB REQUIREMENTS

Work Experience

• At least 8 years of managerial experience preferred.

• At least 10 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$203,000.00 - $305,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.