Senior Director of Quality Systems & Compliance

Medline•Northfield, MN

1d•Onsite

About The Position

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.

Requirements

Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.
At least 8 years of experience related to the design and manufacture of pharmaceuticals, including design controls, risk management, and working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 8 11/12, PIC/S, ICH, and other relevant guidance).
Some Medical Devices Experience also preferred.
At least 5 years of management experience.
Demonstrated ability to develop and execute strategic plans that align organizational objectives with the needs of Quality, Operations, and business stakeholders.
Proven success designing and implementing efficient, risk-based quality systems that meet pharmaceutical regulatory requirements while supporting combination product and drug-device portfolios.
Deep expertise in CAPA systems, investigations, root cause analysis, and quality system remediation.
Strong knowledge of FDA, EU GMP, ICH, and applicable global pharmaceutical regulations.
Experience leading regulatory inspections, quality system transformations, and compliance improvement initiatives.
Depth of technical knowledge of relevant standards and regulations (21CFR 8 11/12, PIC/S, ICH, and other relevant guidance, 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).

Nice To Haves

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.

Responsibilities

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.
Direct and lead the teams in the development of product specifications for all Medline branded products.
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.
Design, implement, and oversee the Pharmaceutical Quality System (PQS) across the organization.
Own and govern key quality system processes, including CAPA, Document Control, Change Control, Management Review, Field Alert Reporting, and Recall Management.
Ensure effective and timely CAPA execution across the Pharmaceutical Quality Organization (PQO) and serve as the organization's CAPA subject matter expert.
Ensure proper reporting, investigation, escalation, and closure of Field Alert Reports in accordance with regulatory requirements.
Establish and maintain an effective training program to ensure personnel competency and compliance across PQO.
Partner with Medline Corporate and Division Quality leaders to ensure complaint handling processes effectively support pharmaceutical operations and regulatory requirements.
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.