Quality Assurance Director Job Description
Quality assurance director
provides engineering support to Receiving Inspection including statistical checkings, measurement systems checkings, Gage R&R studies and inspection procedures.
Quality Assurance Director Duties & Responsibilities
To write an effective quality assurance director job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance director job description templates that you can modify and use.
Sample responsibilities for this position include:
Develop, implement, sustain, and improve Quality Systems to meet FDA regulations, guides, guidelines, ICH, ISO and other regulatory requirements, while maintaining customer satisfaction
Provide cGMP QA direction and coordination to various personnel (internal/external) to assure our products meet FDA regulations and associated guidelines
Ensure Quality Systems include written procedures to ensure QA has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging/labeling materials, and drug products
Develop and revise as necessary, QA and Validation organizational structures that are efficient and support the business needs under management guidance
Recruit, develop, train, and mentor staff such that they have the education, training, experience, or any combination thereof to perform their job functions
Provide direction and coordination of all QA and Validation activities and for other functions that have an effect on product or service quality
Support FDA and other internal/external audits as directed
Report on the performance of the quality system to executive management
Act as a liaison to internal/external parties relating to the quality system
Monitor and improve product and process efficiency by providing an independent audit function
Quality Assurance Director Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Assurance Director
List any licenses or certifications required by the position: ISO, ASQ, CLIA, HACCP, PCQI, GMO, AS9100, 9001, ITIL, SQF
Education for Quality Assurance Director
Typically a job would require a certain level of education.
Employers hiring for the quality assurance director job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Science, Technical, Education, Business, Management, Computer Science, Chemistry, Manufacturing, Biology
Skills for Quality Assurance Director
Desired skills for quality assurance director include:
Python
Databases and SQL
Javascript
Excel
Actimize
Capability studies
Control Plans
FMEA
MSA Gage R&R
Microsoft Word
Desired experience for quality assurance director includes:
Review batch documentation and disposition products
Review raw materials and packaging components records and disposition accordingly
Review and approve deviation and investigation reports
Investigate and respond to customer complaints
Lead fast-paced, high-volume function to implement optimal approach to delivering HMH products to agreed-upon quality and optimal HMH user experience
Evaluate and select outsource partners and vendors for quality assurance activities
Quality Assurance Director Examples
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Quality Assurance Director Job Description
Job Description Example
Our innovative and growing company is hiring for a quality assurance director. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality assurance director
- Manages quality assurance personnel and projects to assure compliance with client and regulatory requirements
- Ensures implementation and maintenance of quality systems including but not limited to SOP writing, batch record review, deviations, technical report review and personnel training
- Key liaison between company and clients regarding Quality and Regulatory issues
- Oversees batch record audits and assures proper batch release documentation
- Assures appropriate reviews and approvals of manufacturing and aseptic filling records for execution for product release
- Takes lead role in organizing and completing investigations, coordinates with other departments involved, and drives closure in a timely manner
- Manages audits, including audit preparation, execution of the audit, the audit report, and follow up to any finding
- Provides trend analyses to peers and senior management
- Assures that all corrective actions are completed in a timely manner and verifies their implementation
- Ensures adherence to cGMP and GLP requirement and SOP’s
Qualifications for quality assurance director
- QA Standards, Methodologies, CMMi, TMMi & audit requirements
- Twelve years of experience in software development, testing, program management and analysis including Bachelor’s degree from an accredited college/university in technical sciences or information systems
- Occasional normal lifting or movement when reviewing products
- Ability to closely partner with customers to adopt the management system and manufacturing methods to meet cGMP and applicable 21CFR820 and European Notified Body Requirements
- Experiences that effectively use continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives
- Engage with the CSD Division Commercial and Operations leadership teams to define the strategy and future requirements for the Quality Management System
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Quality Assurance Director Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of quality assurance director. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality assurance director
- Facilitate Management Reviews, Complaint Investigations, post market compliance requirements and oversee BU compliance activities
- Work closely with various BU functions and other quality functions in ensuring that all aspects of product development, product sustaining, and externally supplied product and post market activities are conducted in a manner that it meets BSC and regulatory requirements
- Work very closely with various manufacturing plants in ensuring product development, manufacturing, and sustaining .
- Support qualification/validation of GxP related computer based systems
- Maintains knowledge of potential licensing and third party collaboration opportunities, completes risk assessment and conducts assessments as applicable, providing risk and mitigation recommendations
- Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise
- Works closely with the applicable QA TA Head and clinical/project/functional teams to understand customer needs in order to develop, refine and adjust strategies and plans, implementing QA activities
- Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements)
- Monitors trends, identifies quality issues and determines opportunities for quality improvements within customer areas and QA
- Be able to analyze and leverage quality indicators and data to identify potential trends and risks, and perform root cause analyses to enable principles of knowledge based auditing within respective TA
Qualifications for quality assurance director
- Working knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211), ICH Guidelines for Manufacture of API’s and practical experience in auditing practices and procedures
- Demonstrated ability to dictate detailed directions in a laboratory environment
- Minimum BS degree in Chemistry or related life sciences discipline required
- Ten-plus years of experience in GCP quality and compliance management in pharmaceutical industry
- Bachelor’s degree in scientific or allied health field
- 15+ years total experience across operations, quality, vendor management, procurement, or other relevant technical activities in global product/technology-oriented businesses
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Quality Assurance Director Job Description
Job Description Example
Our innovative and growing company is looking for a quality assurance director. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality assurance director
- Member of the China Project Core Team
- Establish processes to ensure that new product enhancements are functioning as designed and meeting the needs of bswifts clients
- Management and hands-on development and maintenance of test plans and test cases covering functional product, integration, performance, for automated and manual testing
- Manage test execution cycles to meet product and integration release schedules
- Develop a top-notch QA team through coaching and counselling employees
- Provides leadership and guidance to Quality, Manufacturing, Development, Research and Sourcing departments
- Communicates and escalates issues to Sr
- Ensure an appropriate work force planning (5 years ahead) for the department
- Ensure efficient communication of required information to all appropriate customers
- Ensure that the clinical research program, including investigational product development, adheres to all federal regulatory requirements and ICH guidance on Good Clinical Practice and Good Manufacturing Practice
Qualifications for quality assurance director
- Minimum BS degree in Life Science or related discipline
- RPh,/PharmD, RN, MD/DO and more than 7 years of equivalent experience preferred
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems
- Demonstrable computer skill
- Ability to freely travel up to 30%, (domestic and international)
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Quality Assurance Director Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality assurance director. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality assurance director
- Report directly to the VP – Clinical Research Compliance
- Ensure that the clinical research program, including investigational product development, adheres to all federal regulatory requirements and ICH (International Center for Harmonization) guidance on Good Clinical Practice (GCP)
- Plan for and oversee all internal and external auditing and monitoring across clinical research program and manufacturing facilities to ensure compliance with institutional, federal and other applicable clinical research regulations
- Assesses continual process and performance improvement for the areas of control to ensure most efficient use of assets and resources are achieved while maintaining and improving quality of service to various customers, adherence to controls, and certain regulatory requirements
- Develop, implement, and maintain tools and systems that will be used to achieve the process and performance improvements previously noted
- Participates in key decisions pertaining to strategic initiatives, operating model and operational execution as it pertains to their areas of responsibility
- Drives all tasks necessary to achieve the organization’s mission and execute growth plans as required by their areas of responsibility
- Update Plant Food Safety Plans from HACCP- based to FSMA’s HARPC compliance
- Enforce document investigation
- Direct accountability for setting up strategy, planning and execution of the end to end testing including automation
Qualifications for quality assurance director
- Regulatory compliance knowledge and skills are required
- Remains current on regulations and guidelines related to the conduct and reporting of clinical trials
- Ability to interface and influence Executive management
- Knowledge of testing custom hardware with firmware and embedded software
- Experience with end to end life cycle requirements, development and testing of multiple releases
- Experience reviewing and auditing study-related documentation
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Quality Assurance Director Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality assurance director. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality assurance director
- Manage performance and development of all SSO Quality Assurance systems/processes, personnel, budget and goals as needed
- Report and/or escalate identified and prioritized quality metrics, deviations, issues and opportunities for improvement to personnel, management and physician leadership as applicable
- Oversee, manage and/or facilitate external audits and assessments and regulatory agency inspections
- Modify policy and procedure for its supporting functional groups to include but not be limited to, update of SOPs, contracts, and project documentation
- Ensure that the QMS is followed by requiring action plans as needed (i.e., audits, Corrective Action/Preventive Action (CAPAs), Non Conformance)
- Manage personnel who execute the plans to completion as needed
- Provide feedback on requirements and functional specifications
- Monitors the key quality performance measures and the corrective action results
- Identify quality assurance metrics
- Manage team of QA engineers – career planning, training, project assignments, support
Qualifications for quality assurance director
- 8+ years of relevant experience in Quality Assurance and software development
- Minimum of a Bachelors degree in business, engineering, computer science or marketing
- Strong knowledge of software development life cycle and the importance of QA involvement throughout the entire cycle
- Experience testing business solutions delivered on SaaS models
- ASQ Certifications (CQM/OE preferred)
- Ten (10) or more years of QA or related experience