Director Quality Pharmaceutical Manufacturing - Waukegan, IL

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.