Senior Director of Quality Operations

Medline•Northfield, MN

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 manufacture of pharmaceuticals including c GMP, risk management, and working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 11/12, PIC/S, ICH, and other relevant guidance).
Some Medical Devices Experience also preferred.
At least 5 years of management experience.
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).

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 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.