Senior Director of Quality

Posting Date 2 weeks ago(11/10/2021 4:50 PM)
Requisition ID
2021-9838
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Quality

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Senior Director of Quality at Cook MyoSite will be accountable for the global development, implementation, and management of the Quality Management System (QMS) for clinical and commercial operations and to create, communicate, and implement a clear strategic vision for building quality principles into systems and processes, and for driving a culture of operational excellence to fashion a competitive advantage for the company’s products and services.

 

Responsibilities

• Participate with other executives in formulating current and long-range strategies, objectives, and global policies.
• Assume the overall leadership for the Quality functions and develop, implement, prioritize and communicate the Company’s quality strategy, mission and vision.
• Direct and provide support to the Quality Control Unit (quality assurance, quality compliance, and quality control)
• Provide strategic direction to the Quality approach across the business.
• Set quality standards.
• Identify business and quality risks and facilitate their mitigation through focused teams.
• Ensure all our customers are represented when making relevant decisions.
• Create a strong quality culture, not just a culture of compliance, and lead by example.
• Prepare management team members and staff for regulatory inspections, including Pre-Approval Inspections (PAI) or routine facility inspections.
• Give direction towards building a fully functional, commercial QMS that is also flexible and supportive of the needs of the developmental aspects of the company including clinical and non-GMP activities.
• Ensure QMS systems support the company’s overall Quality policy and meet cGxP compliant regulatory requirements.
• Ensure elements of the QMS are scalable globally to meet compliance requirements.
• Ensure the quality standards of domestic and global partners and affiliates align with internal culture.
• Ensure Quality Management Reviews are conducted for sites, and corporate functions.
• Develop and implement employee communication and training programs in connection with the Company’s Quality objectives, strategies, and processes.
• Provide advice, counsel and direction to executive and management teams, the Quality team, and other staff.
• Build financial assessments into quality functions for budgeting purposes.
• Provide the guidance necessary to ensure that the appropriate level of risk management is used when making quality decisions.
• Build ‘right first, every time’ mentality within organization.
• Build a Team of highly motivated and experienced quality professionals.

Qualifications

• Undergraduate or master's degree in Quality, Regulatory Affairs, Pharmacy, Chemistry, or Biology is required

• Minimum of 15 years' experience in Biotechnology is preferred

• Minimum of 10 years’ experience in Quality with exposure to cGMP environment in cell therapy/regenerative medicine field is preferred
• Experience in both development and commercial manufacturing environments is preferred
• Knowledge of FDA and foreign regulatory requirements as well as industry quality management tools, trends, practices, standards, and the quality system is preferred
• Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology, and laboratory operations in a manufacturing environment is preferred
• Minimum of 3 years’ experience in Operations is preferred

• Ensures directorate is managing and meeting annual budget in accordance with the annual budgeting timeline.
• Responsible for short and longer-term company impacting decisions and output.
• Effectively delegates and follows up on completion of work.
• Regularly and consistently provides status reports on all active projects and initiatives.
• Develops, reviews, and enforces company policies.
• Ability to present highly complex information to a broad audience in a clear and comprehensive manner.
• Is an effective communicator with internal and external stakeholders. Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner.
• Acts as management with executive responsibility.
• Oversees direct reports: Creates and executes short and long-term staff development plans.
• Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.
• Ensures that directorate status meetings are held on regular basis and conducts routine one on one meetings with direct reports.
• Directly responsible for directorate staff resource planning.
• Responsible for departmental hiring decisions and participates in recruitment of staff.
• Makes decisions and ensures the successful completion of strategic initiatives that are aligned with quality, operational and business best practices.

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

 

Physical Requirements:

• Office Setting (with travel): General office, warehouse and laboratory setting.

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

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