Head Of Quality Management
By Invitae At San Francisco, CA, United States
Exceptional leadership and people management abilities, with a focus on building and developing high-performing teams
Create and monitor systems that enable the effective governance, risk management and administration of the QMS
Proven experience in the field of Clinical Laboratory Medicine that emphasizes complex testing in a high-throughput setting
15+ years of experience leading Quality Assurance/Regulatory Affairs organizations
Global business experience, including international QMS standards such as ISO9001, ISO15189 and ISO 13485
Excellent understanding of regulatory requirements and compliance standards relevant to the industry
Head, Quality Assurance Operations
By Novartis At , Morris Plains
Minimum of 5 years People Management experience
Ensures proper training and qualification of all Operational quality assurance associates in team.
Minimum of 7 years experience in the pharmaceutical or relevant industry experience
Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience
Related experience in supporting an operational quality assurance team
Familiar with Lab equipment Validation/Qualification Master Plan &Protocols is desired
Head Of Gxp Quality Assurance
By Egnyte At , Remote $180,000 - $260,000 a year
Own and improve on our Quality Management System, including policies, procedures, and plans
Communication: Excellent written and verbal communication skills and experience working with customers and internal stakeholders
Support customer audits & qualifications
Ensure Egnyte meets regulatory requirements and GxP
Builder: Has experience implementing new processes alongside further improving existing quality processes and documentation.
Competitive salaries, comprehensive benefits & pre–IPO stock options
Head Of Quality/Quality Manager
By Michigan Spring and Stamping, a KERN-LIEBERS Company At Muskegon, MI, United States
Five to eight years direct experience in quality control management, preferably in a spring environment.
Acts as the Management Representative for Michigan Spring and Stamping’s registered quality systems.
Proven experience as a quality manager
Excellent math abilities and working knowledge of data analysis/statistical methods
Understands customer needs and requirements to develop effective quality control processes
Conducts and/or manages studies to determine cause, effect and corrective measures required to remedy deviations impairing desirable standards of quality.
Head Of Quality Control
By Mackenzie Stuart At Nevada, United States
10+ years of experience in quality management, preferably in the dietary supplement industry
Building and managing effective Quality Management Systems (QMS)
Overseeing Quality Assurance activities, optimizing quality management systems, change control, risk management
Ensure compliance with FDA regulatory requirements
Leading Quality Control efforts, including QC procedures and policies, analytical methods, and laboratory qualifications
Developing and executing the Quality strategy
Head Of Quality Operations
By EPM Scientific At Tennessee, United States
Strong leadership and organizational skills, with experience managing teams of 10 or more people.
Manage external client relationships related to quality assurance and ensure their needs are met.
Managing a growing team of 20 to 50 technicians & managers while continuing to develop positive company culture.
Experience in managing external client relationships and working with CROs/CMOs.
20 to 50 technicians & managers while continuing to develop positive company culture.
The Head of QA should have the following qualifications….
Director, Head Of Quality Compliance
By Meet At New Jersey, United States
Main POC with the FDA, management of external vendors
Experience with large molecules, biologics (ideally experience in monoclonal antibodies)
BPDR - Biological Product Deviation Report experience
Director, Head of Quality Compliance – Competitive Salary + Benefits
To be successful in this role, your experience will need to include
Establishing the Quality department on a new site
Site Head Of Quality
By Life Science People At Pleasanton, CA, United States
Certifications in quality management (e.g., Six Sigma, Lean) are highly desirable.
Establish and maintain a robust quality management system, including documentation control, change control, and deviation management.
Strong knowledge of regulatory requirements, such as FDA regulations, GMP guidelines, and ICH guidelines.
Proven track record of implementing and managing a quality management system in accordance with industry standards.
Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle, from development to manufacturing and distribution.
Minimum of 10 years of progressive experience in quality assurance and quality control in the biotech or pharmaceutical industry.
Head Of Quality Assurance Department
By Ergon Inc. At Chandler, AZ, United States
Maintain quality standards/metrics & tracking set by the Crafco Quality Management System
Maintain appropriate records and files of data, instructions, and procedures in Quality Control Management System
BS degree in a technical or management field
Minimum of 5 years related work experience in Quality Assurance, quality certifications a plus
Knowledge on how to run all QC tests for sealant, roofing, silicone and patching materials
Manage external Crafco Technical Product documents (PDS, Installation Instructions, SDS), Certificates of Compliance
Head Of Quality Systems & Validation
By BioSpace At Lexington, MA, United States
Experience with Track Wise Deviation/CAPA, Change Control Management (CCM), SAP and DMAIC philosophy.
Drive digital innovation within Quality Management Systems
Conduct gap analyses and implement Quality Management System procedures
Oversight of all business monitoring type activities, including Quality Council, Management Review, Annual Product Quality Review (APQR) and associated processes.
Establish sustainable business processes are in place for all Quality Management Systems.
Follow domestic and international GMP regulations, cGMP’s, company policies, Takeda leadership behaviors, and conducting performance management
Head Of Quality Management
By Baylor Genetics At United States
Extensive knowledge of quality management systems and quality improvement tools and techniques such as Six Sigma or Lean.
Minimum of 2-4 years in a supervisory role in Quality Management in a certified laboratory
Identify and report quality issues and problems to management with recommendations for resolution.
Ensure sound management of laboratory operations and the development, implementation, and review of internal policies.
Quality Management Systems (50% of duties)
Management and Leadership (15% of duties)
Head Of Quality Assurance
By Discover International At United States
Proven track record of developing and implementing quality management systems in compliance with regulatory requirements.
Experience in leading and managing quality assurance teams, including hiring, training, and performance management.
Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and senior management.
In-depth understanding of risk management practices and their application in the medical device industry.
Strong knowledge of class III Medical Devices
Excellent problem-solving and analytical skills, with the ability to make data-driven decisions.
Head Of Quality Assurance
By Alzheon, Inc. | Preserving Future Memories At Boston, MA, United States
Review and analyze quality trends with Alzheon management team
Evaluate the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of the Alzheon quality management system
Support customer driven quality requirements and ensure vendors and supplier meet Alzheon’ s quality requirements
Firsthand experience of audits by regulatory authorities
Experience in hosting and leading FDA and other regulatory authority audits
Plan, direct implementation, and maintain an effective Quality Systems program in compliance with regulatory guidance and Pharmaceutical industry best practices
Head Of Quality Assurance
By Indenovo Global Search & Selection At Orlando, FL, United States
Strong experience in quality systems management and implementation.
Experience working within Dietary Supplements and/or Pharmaceutical manufacturing.
Extensive knowledge of the FDA code of Federal Regulations.
Lead both QA and QC teams to ensure effective Quality process.
Develop internal process and best practice.
Ensure regulatory compliance across multiple product categories.
Senior Director, Site Head Of Quality
By KBI Biopharma At , The Woodlands, Tx $203,000 - $230,000 a year
Responsible for management, leadership and oversight of the Quality Assurance and Quality Control departments.
Responsible for ensuring site compliance with GMP and regulatory requirements.
Must have thorough knowledge of cGMPs and biotechnology-derived product regulations. Also requires a demonstrated track record in the following key areas:
Strong collaboration and team building skills
Experience developing, implementing, and executing strategic plans and objectives for organizations and departments.
Sterile Manufacturing experience at a GMP Sterile Manufacturing Facility
Head Of Quality Systems & Validation
By Takeda Pharmaceutical At , Lexington, Ma
Experience with Track Wise Deviation/CAPA, Change Control Management (CCM), SAP and DMAIC philosophy.
Drive digital innovation within Quality Management Systems
Conduct gap analyses and implement Quality Management System procedures
Oversight of all business monitoring type activities, including Quality Council, Management Review, Annual Product Quality Review (APQR) and associated processes.
Establish sustainable business processes are in place for all Quality Management Systems.
Follow domestic and international GMP regulations, cGMP’s, company policies, Takeda leadership behaviors, and conducting performance management
Vice President, Head Of Regulatory Affairs And Quality Assurance
By Scorpion Therapeutics At , Boston, 02114, Ma
Ensure the qualification, selection and management of vendors and contractors through a defined qualified process
Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs
Develop and manage Global Regulatory Affairs and QA budgets
Extensive experience leading, designing, writing and submission of regulatory filings and correspondence
Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities
Strong problem solving, critical thinking and analytical skills, required to make sound decisions
Head Of Quality Jobs
By Vedanta Biosciences At , Cambridge, 02139, Ma
10+ years' experience in Quality Management with several years in a biotherapeutics manufacturing setting
A proven track record of leadership, people management, and effective interpersonal and communication skills
Manage, develop, and build the Quality team and its capabilities
Deep knowledge of cGXP requirements, with an understanding of phase-appropriate clinical and commercial expectations
Lead the expansion of the QMS, including strategic implementation of electronic systems to support internal CGMP capabilities for our LBPs
BS/MS in a relevant scientific discipline (e.g., Microbiology, Biochemistry), 15+ years of relevant professional experience
Head Of Quality Operations
By EPM Scientific At United States
Strong leadership and organizational skills, with experience managing teams of 10 or more people.
Manage external client relationships related to quality assurance and ensure their needs are met.
Managing a growing team of 20 to 50 technicians & managers while continuing to develop positive company culture.
Experience in managing external client relationships and working with CROs/CMOs.
20 to 50 technicians & managers while continuing to develop positive company culture.
The Head of QA should have the following qualifications….
Senior Director, Head Of Quality
By Abdera Therapeutics At San Francisco Bay Area, United States
Prior experience and knowledge in implementing Quality Management System and electronic document control systems.
Direct development, initiation, and maintenance of all Quality Systems in support of the product(s) including the Quality Management Review.
Competence in FDA and international GMP requirements. Strong working knowledge of GCP beneficial.
Manage external consultants, as required.
Minimum of ten (10) years of Quality Assurance experience in FDA regulated industry, preferably, biologic or Antibody Drug Conjugate therapeutics.
Prior experience with IND and early clinical stage oncology programs.

Are you looking for an opportunity to lead a team of quality assurance professionals and make a real impact on the success of a company? We are looking for an experienced Head of Quality Assurance to join our team and take our quality assurance program to the next level. If you have a passion for quality and a commitment to excellence, this is the job for you!

Overview:

The Head of Quality Assurance is responsible for ensuring the quality of products and services provided by the organization. This includes developing and implementing quality assurance policies and procedures, monitoring and evaluating quality assurance activities, and providing guidance and support to staff.

Detailed Job Description:

The Head of Quality Assurance is responsible for developing and implementing quality assurance policies and procedures, monitoring and evaluating quality assurance activities, and providing guidance and support to staff. The Head of Quality Assurance is also responsible for ensuring that products and services meet the organization’s quality standards. This includes conducting audits, analyzing data, and making recommendations for improvement. The Head of Quality Assurance will also be responsible for developing and maintaining relationships with external suppliers and customers.

What is Head Of Quality Assurance Job Skills Required?

• Strong organizational and problem-solving skills
• Excellent communication and interpersonal skills
• Knowledge of quality assurance principles and practices
• Ability to work independently and as part of a team
• Ability to manage multiple tasks and prioritize effectively
• Proficiency in Microsoft Office Suite

What is Head Of Quality Assurance Job Qualifications?

• Bachelor’s degree in Quality Assurance, Business Administration, or related field
• 5+ years of experience in quality assurance
• Knowledge of ISO 9001 and other quality assurance standards
• Experience with quality assurance software
• Certification in quality assurance is a plus

What is Head Of Quality Assurance Job Knowledge?

• Knowledge of quality assurance principles and practices
• Knowledge of ISO 9001 and other quality assurance standards
• Knowledge of quality assurance software

What is Head Of Quality Assurance Job Experience?

• 5+ years of experience in quality assurance
• Experience with quality assurance software

What is Head Of Quality Assurance Job Responsibilities?

• Develop and implement quality assurance policies and procedures
• Monitor and evaluate quality assurance activities
• Provide guidance and support to staff
• Ensure that products and services meet the organization’s quality standards
• Conduct audits and analyze data
• Make recommendations for improvement
• Develop and maintain relationships with external suppliers and customers