Senior Manager of Quality Control

Posting Date 1 week ago(6/3/2021 3:17 PM)
Requisition ID
2021-9097
Job Location(s)
Pittsburgh PA United States
Travel
None
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 Manager, Quality Control for Cook Myosite will plan organize, direct, and evaluate the routine activities and project deliverables of the Quality Control (QC) Laboratories, to ensure the safety and reliability of products manufactured in compliance with requirements. Interface with and support manufacturing operations and technical services by setting strategy for QC activities, including testing of materials, in-process materials/products, finished goods, and stability studies, as well as environmental monitoring (EM), contamination control, and aseptic operations. The position requires leadership, technical, and business expertise.

 

Leadership: Develop & implement direct strategy for QC. Monitor performance. Ensure efficient, effective, compliant activities. Provide guidance and coaching of direct reports, including FLM(s) and Scientists/Specialists. Interface with other departments.

 

Technical: Provide direction for discussions and informed decisions on relevant topics, including method development, qualification/validation, and transfer for compendial and non-compendial assays. Contribute expertise supporting projects, audits, investigations, CAPAs, change controls, policies/procedures, documents, and protocols/reports.

 

Business: Establish, maintain QC budget. Determine work-load capacity of QC. Provide input on staffing, training, and equipping. Develop, approve contracts, requisitions, purchase orders, projects, and invoices.

Responsibilities

• Organize, direct, evaluate routine activities and project deliverables of the QC Laboratories

• Ensure efficient, effective, compliant operation, including staffing, training, as well as equipment, rooms, and systems

• Serve as subject matter expert (SME), provide input on strategy, execution, and report-out

• Make informed decisions

• Work collaboratively with other departments

• Provide guidance on method development, qualification/validation, transfer, and execution

• Contribute expertise needed on projects and other company work

• Collaborate on, review, and approve relevant policies, procedures, specifications, protocols, and reports

• Ensure proper management of the QC document lifecycle. Interact with health authorities and customer representatives

• Ensures directorate/department is managing and meeting annual budget
• Primarily responsible for organization functional area decisions and output
• Establishes and report-out on meaningful metrics to established time periods
• Effectively delegates and follows-up on completion of work
• Regularly and consistently provides status reports on all active projects and initiatives to appropriate Executive Leadership
• Enforces and exemplifies 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 listen to input and responds to feedback appropriately and in a timely manner
• Is action-orientated and follows-up on feedback to ensure positive outcomes
• Accountable for all stated responsibilities including progress, accuracy, and timely completion of objectives
• Is a critical thinker with proven problem-solving and decision-making abilities
• Ensures company maintains focus on our customers
• Exhibits well-developed prioritization, planning, organization, and time-management skills
• Possesses the ability to develop and implement complex processes, procedures, and systems within and across functions
• 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 departmental status meetings are held on regular basis and conducts monthly one-on-one meetings with direct reports
• Directly responsible for organizational/function staff resource planning
• Identifies and develops resource needs and develops processes
• Responsible for departmental hiring decisions and participates in recruitment of staff
• Makes day-to-day strategic decisions that are aligned with quality, operations, and the business
• Works closely with executive leadership on strategy development, execution plans, and reporting
• Ensures clarity through regular and consistent communication of the priorities and goals for the entire functional area

Qualifications

• Concentration in applicable life science (Chemistry, Analytical Chemistry, Biochemistry, and/or Biology) or equivalent:
  - Advanced scientific degree (i.e., MD, PharmD, PhD) and at least 4 years’ experience in Bio/Pharma GMP; or
  - Master’s degree and at least 5 years’ experience in Bio/Pharmaceutical GMP; or
  - Bachelor’s degree and at least 6 years’ experience in Bio/Pharmaceutical GMPAdvanced proficiency in Microsoft Office including Word, Excel, and Outlook
• Working knowledge of Adobe, Microsoft Teams, OneNote, Labware LIMS, Sage, and MasterControl useful
• In-depth understanding of cGMP and related regulations and pharmacopoeia associated with Bio/Pharmaceutical manufacturing for the US, EU/UK, Canadian, and Japanese markets, and relevant guidance, requirements, best practices, and industry standards (e.g. FDA, MHRA, EMA, ICH, ISPE, and ISO)

• Strong working knowledge of pharmacopoeia and requirements for testing and validation pertaining to the Bio/Pharmaceutical GMP industry, especially for aseptic manufacture of clinical and commercial cell therapy products / regenerative medicine, experience executing and validating analytical test methods (FTIR, flow cytometry, PCR, cell counting, cell-based bioassays, etc.)
• Experience driving company goals and objectives, policies and procedures, compliance with health authority regulations, guidance, and standards

• Proven capabilities in reviewing and approving analytical procedures, specifications, method transfer development reports and method transfer reports
• Advanced knowledge and implementation of data integrity principles
• Experience making good decisions in a timely manner, based on a mixture of analysis, education, wisdom, experience, and judgment
• Strong leadership skills with experience in managing, supervising, and developing employees and teams. Ability to interface effectively with management and other groups, project teams, departments, and cross-functional representatives. Excellent interpersonal skills with ability to handle conflict effectively
• Experience managing multiple activities and priorities concurrently to accomplish goals. Ability to use resources effectively and efficiently
• Experience driving self and others to meet expectations, requirements, and needs
• Solid interpersonal, verbal, and written communication skills. Ability to communicate and collaborate effectively with multiple levels within the organization to achieve success and measurable results
• Understanding of the need to focus on quality culture and safety
• Comfort with fast-growing company transitioning from R&D to commercial in GMP environment
• Ability to work autonomously, with minimal direction
• Ability to adjust workload based on changing priorities
• Advanced organizational and time management skills
• Working knowledge of Laboratory Information Management Systems (LIMS) and experience in leading LIMS implementation and optimization. throughout an organization
• Experience and involvement with regulatory audits/inspections, as well as internal and external audits

 

Physical Requirements:

• Laboratory Setting (Non-Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.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
• Ability to spend majority of day standing in laboratory setting or sitting at/working in a biological safety hood with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), appropriate shoes, and facial mask (if required) on a regular basis

 

 

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