QA Head Job Description
QA head
provides oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
QA Head Duties & Responsibilities
To write an effective QA head job description, begin by listing detailed duties, responsibilities and expectations. We have included QA head job description templates that you can modify and use.
Sample responsibilities for this position include:
Benchmark application group’s QA services related to system/integration and user and business acceptance testing to best-in-class industry organizations
Assumes a management role across IT and the business units by creating and executing a strategy for maintaining and promoting testing methodologies and tools
Oversees the review and audit of documentation for compliance to good documentation practices and to the technical requirements of directive documents (SOPs, protocols, directive documents)
Directs internal and external audits and assists departments with the coordination of audit information, and recommends appropriate improvement/mitigations
Be a single point of accountability for the creation, implementation and success of the Retail Applications QA Program, driving the evolution of the QA program for greater efficiency and effectiveness
Contribute to development and implementation of QA Governance processes and associated reporting metrics
Contribute to development and implementation of continuous improvement criteria and measurements
Establish and drive strategic and tactical QA initiatives and plans
Partner with Process and Methodology COE (Centre of Excellence), Infrastructure Services and Process Project Office, other QA groups within Technology & Operations
Directs the software automation effort by identifying and prioritizing opportunities that will maximize benefits from test automation and develop/implement test automation solutions to deliver those benefits (cost saving and risk reduction)
QA Head Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Head
List any licenses or certifications required by the position: ASQ, QA, CAMS, QP
Education for QA Head
Typically a job would require a certain level of education.
Employers hiring for the QA head job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Pharmacy, Life Sciences, Chemistry, Science, Computer Science, Life Science, Management, English, Education
Skills for QA Head
Desired skills for QA head include:
Audit
Biologics and pharmaceutical products
Business
CAPA
Compliance issues
Data integrity
Deviation investigation
External regulatory bodies and auditors
GMPs
GxP and food regulations
Desired experience for QA head includes:
Ensure effective execution of annual QA plan by the QA team
Work with issue owners on effective remediation, remediation ownership and challenge of remediation efforts
Issue a QA report at the completion of each QA outlining scope, approach and findings with management action plans
Bring to management’s attention any issues which may affect the accuracy of regulatory reports filed or the control environment supporting regulatory reporting
Support the development of financial reporting and regulatory reporting frameworks for the Intermediate Holding Company (IHC)
Management experience in a regulated environment
QA Head Examples
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QA Head Job Description
Job Description Example
Our growing company is hiring for a QA head. 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 QA head
- System Administration of QC Applications including Empower (future NuGeneses, LIMS)
- Prepare, review and update Software/Hardware Qualification Documents, Change Controls, Corporate Policies, Guidelines, SOP's
- Directs staff of QA media operations specialists that review and approve device master records, batch records, testing, and aseptic operations
- Provides oversight of aseptic operations including managing QA on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820)
- Provides direction for complex deviations and complaint investigations
- Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications
- Exceptionally well organised and proactive and ability to deal with ambiguity
- Leadership across a matrix of IT functions to deliver results
- Create/Originate written procedures for the evaluation of raw materials, in-process samples and finished product with a high degree of precision and accuracy according to the U.S. FDA rules, guidelines, and industry standards
- Oversee implement/execution written procedures for the evaluation of raw materials, in-process samples and finished product with a high degree of precision and accuracy
Qualifications for QA head
- A minimum of a bachelor’s degree is required and an advanced degree is preferred
- 10+ years of relevant, hands on experiences, 5+ years in senior level management role leading teams across multiple countries
- Proven experiences with Agile software development and testing are mandatory
- Strong customer-service focus for building products balancing resources vs speed to market
- Ability to motivate and grow a collaborative, cross-functional team with a track record for quality, on-time deliveries
- Excellent English-language writing and speaking
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QA Head Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of QA head. 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 QA head
- Coordinates with other departments leaders to maximize efficiency and compliance
- Collaborate with development groups for method transfer and qualification activities as required
- Participate in cross-team efforts to develop, validate, and implement quality control test methods for new projects
- Independently analyze and approve data generated by quality testing to ensure specification and regulation are met for each type of test and project
- Complete sophisticated documentation requirements for all GMP activities following GMP Good Documentation Practices (GDP)
- Independently make decisions in regards to maintain quality standards within the department
- Effectively communicate deliverables and expectation to Quality Control Staff
- Delegate duties and responsibilities to staff
- Provide organizational leadership, direction and training in areas such as QA, QC, safety, cGMP, GDP, productions, team leadership
- Provides final decisions for critical assessments for each project through the monitoring of incidents and CAPAs
Qualifications for QA head
- Willingness to connect with global colleagues at off-hours
- Bachelor’s degree in a life science or equivalent required
- Minimum 10 years in R&D, Data Management or Quality Assurance in a Pharmaceutical environment
- Knowledge of R&D related US, EU, ICH regulations, guidance’s and requirements
- Strong knowledge of MS Office and Data Analytics applications
- Basic knowledge of Statistics is required
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QA Head Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of QA head. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA head
- Distinguished by additional specialized knowledge in breadth and/or depth, record of success in relevant business process/function
- Oversees all customer, regulatory and in-house audits
- Responsible for the disposition of each project’s mission/goals, deliverables, resources, key participants (internal and external), deadlines, gaps and risks related to sponsorship guidelines, contract specifications, and federal code related to the research process ultimately leading to a pipeline to commercialization
- Provide direction and feedback on issues along with coordinating responses to client related issues to BioMARC Director, CSU Quality representatives and the sponsor
- Establishment, maintenance and adherence to all customer policies and procedures as stated in Agreements
- Ensures BioMARC’s adherence to all regulatory rules and regulations, ensuring that safety and product performance standards are met
- Act as the Sr
- Builds and maintains a quality infrastructure that can ensure that activities and manufacturing records are in compliance with SOPs and regulatory requirements, determines the need for corrective actions, ensures proper documentation, and determines effectiveness of the action
- Responsible for recognizing and managing each project’s mission/goals, deliverables, resources, key participants (internal and external), deadlines, gaps and risks related to sponsorship guidelines, contract specifications, and federal code related to the research process ultimately leading to a pipeline to commercialization
- Approval of organization’s expectations for testing, control, development study and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met
Qualifications for QA head
- Mature professional dealing with complex stakeholder structure
- SQL, Data Warehousing or Data Modeling experiences a plus
- Degree or PhD in Life Sciences, Pharmacy or Medicines
- Considerable organization awareness
- Degree in Engineering/Applied Science with minimum 6 years of working experience or equivalent
- Work ethic must include being detail oriented and thorough
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QA Head Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of QA head. 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 QA head
- Drive and guide Clinical Study Teams on process and necessary lead times
- Deliver proper management of products throughout product lifecycle (launch of new products, market release, CAPAs, deviations, recalls)
- Accountable for establishing a Process Quality Engineering practice in the area of Risk Management
- Accountable for establishing the policies/standards of performance of the Process Quality Engineering work in scope including risk analyses, risk evaluation, risk mitigation plans and activities, risk control plans and risk files
- Expert knowledge of Risk Management Principles and practices including Safety Risk Management (ISO 14971), UFMEA and DMFEA
- Accountable for establishing a Process Quality Engineering practice at SVAL level
- Accountable for establishing the policies/standards of performance of the Process Quality Engineering work in scope including risk analyses, risk mitigation plans and activities, control plans, calibration plans and records and environmental controls
- Ensures that appropriate standards and design transfer processes are in place for both NPI’s, for ongoing manufacturing that include all stages of the manufacture of the product/system
- Ensure consistent standards and processes are in place to detail which processes need validation/re-validation after changes, and verify processes and plans/records
- Works on complex manufacturing quality engineering/assurance issues where analysis of situations or data requires an in-depth knowledge of the company
Qualifications for QA head
- Responsibility for maintenance and improvement of all GMP-related quality systems relevant for the site Marburg
- Ensures preparation, successful conduct and follow-up of all regulatory inspections, self inspections, and customer audits oversight over relevant GSQ activities to enable unrestricted pharmaceutical operations in Marburg
- Ensures the development and implementation of Quality Risk Management for quality systems GMP processes covering clinical trial material and commercial products
- Ensures maintenance and development of electronic quality systems
- Ensures timely issuance of the Annual Product Quality Reviews (APQRs) maintenance and further development of the quality review system
- Ensures efficient coordination of general quality and compliance related activities with Global Supplier Quality, R&D Quality (GCP, GVP), Logistics Quality (GDP) and affiliates
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QA Head Job Description
Job Description Example
Our innovative and growing company is looking for a QA head. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA head
- Build and maintain expertise in cell therapy QA teams for cell therapy
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work and promptly report actual potential accidents and injuries
- Adherence to cGMP`s is required at all times during the manufacture of API and Drug Product
- Establishing a Process Quality Engineering practice with a focus on Reliability
- Establishing the policies/standards for quality and reliability performance of the System/Product Quality Engineering work in scope including Quality & Reliability management
- Performing independent technical assessment on product quality reliability performance and post-market product reliability analysis
- Being a coach/mentor and single point of contact to a project team, ensuring that hardware design meets quality and reliability standards for every milestone
- On the longer term you may manage a small team
- To ensure that an effective Quality Assurance function is established in the Process Unit and to ensure that quality systems are operated to ensure compliance with regulatory requirements, the Quality Manual, standards & best practice and Site Wide Quality Systems
- To establish quality objectives and KPI’s for the Process Unit Organization and to ensure these objectives are met and that continuous improvement is demonstrated
Qualifications for QA head
- Ensures compliant Quality document management with a focus on
- Knowledge of scientific applications such as Empower, LIMS, NuGeneses
- Writing and / or review of IQ, OQ and PQs and other validation documents
- Software engineering methodology
- Management of vendors to meet deadlines
- 10 Years in the Specific Field