Director Quality Assurance, Pharmaceutical Manufacturing

Job Summary

Responsible for providing leadership and direction to Quality team(s) to ensure quality and compliance for the applicable products and processes for assigned department(s) at the manufacturing site. Develop strategy, translate into functional plans and guide execution of long-term goals.

Job Description

Responsibilities:

• Management Representative for the site to ensure quality and regulatory compliance with applicable regulations (e.g., QSR, PQS, GMP, ISO, ICH) pertaining to the product's applicable life cycle and regions of distribution.
• Partner with Plant Operations to ensure optimal collaborative, effective relationships and drive continuous improvement.
• Develop and implement a strategy for the Quality department(s) based on the Quarterly Management Review.
• Ensure the Manufacturing site readiness for internal audits, external regulatory audits, and customer visits.
• Act as liaison with Senior Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Oversee procedures for inspection and ensure test methods are followed for incoming, in-process, and finished product release to ensure product is in alignment with applicable regulations
• Oversee QSR/QMS/PQS for assigned department(s) and ensure compliance as measured by FDA/ISO/internal audits.

Management responsibilities include:

• Typically, manages through multiple Managers. Provides leadership and management to site QA/QC teams.
• 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.

Qualifications:

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO/PQS/ICH requirements or other regulated industries (21CFR 820, 21CFR 210/211, ISO 13485, ISO 14971, MDSAP, and MDR).
• Depth of technical knowledge of relevant standards and regulations (21CFR 820, 21 CFR 210/211, 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).

Preferred Qualifications:

• At least 6 years of managerial experience preferred.
• At least 8 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:

$154,000.00 - $231,000.00 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.