Quality Assurance Senior Manager Job Description
Quality assurance senior manager
provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures, regulations and guidelines.
Quality Assurance Senior Manager Duties & Responsibilities
To write an effective quality assurance senior manager job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance senior manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Utilize a quality approach, to ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
Monitors the project management reporting and project control environment within the bank
Identifies and implements improvements to the PM QA processes, procedures and overall project management control environment based on input from key stakeholders
Continually advances the professional practice
Principal contact in the business for AML/Client Due Diligence to guide the business on what KYC/CDD documentation is required
Sign off new business within parameters set by AML Compliance
Ensure new business outside parameters is escalated and signed off by AML Compliance or the relevant High Risk committee
Liaise with central AML Compliance team to agree on exceptions and reduced/enhanced due diligence requirements for the business signing off any within parameters set by AML Compliance
Arrange and deliver ongoing training across the business on KYC/AML initiatives and changing requirements
Monitor and follow up on outstanding Client Due Diligence Issues
Quality Assurance Senior Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Assurance Senior Manager
List any licenses or certifications required by the position: ISO, ASQ, CPA, CMMI, QA, CIA, US, 9001, CISA, CFR
Education for Quality Assurance Senior Manager
Typically a job would require a certain level of education.
Employers hiring for the quality assurance senior manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Computer Science, Technical, Education, Chemistry, Business, Management, Biology, Finance
Skills for Quality Assurance Senior Manager
Desired skills for quality assurance senior manager include:
CGMP/cGTP regulations and guidelines
Experience implementing Quality Systems in a regulated environment
Industry practices
SharePoint
/selective media and confirmatory procedures
Bacteria morphology and understanding of biochemical characteristics for bacteria identification
Coverage
GCP
Lean and Six Sigma methodologies
PV regulations and guidelines local regulations
Desired experience for quality assurance senior manager includes:
Actively participate in product release process - from scope definition, planning, design and delivery
Experience with Agile and Waterfall methodologies and be able to work in the mixed approach
Experience managing products supported on both Windows and Linux-based operating systems in virtualized and cloud environments
Manage release activities for major, minor and patch releases - reporting key metrics and decision making and taking actions accordingly
Provide day to day technical guidance and hands on help to engineers, mentorship at every level
Familiar understanding of networking concepts from switching, routing, security firewalls and load balancers
Quality Assurance Senior Manager Examples
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Quality Assurance Senior Manager Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality assurance senior manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality assurance senior manager
- Review the business and financial risk strategy assessments and the financial analysis with reference to financial reports obtained from the clients
- Document the results of the post loan review and discuss the major concerns with the directors
- Escalate issues to the appropriate authorities whenever necessary
- Responsibilities include but are not limited to development of regulatory strategies to meet regulatory requirements, project and business goals
- Conduct Investigator, Vendor and Internal Audits
- Aid in the identifying risks and mitigation techniques that support Good Clinical Practice
- Aid in the conduct of clinical document audits in support of clinical studies and regulatory submissions
- Support external/internal audit activities, including review of monitoring reports, Essential Documents and other supportive documentation required by regulatory agencies, or customers, to support the quality assurance function
- Support inspections by regulatory agencies by assisting in the organization of and preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections
- Participates in the reviewing of engineering designs, production process, supplier process to contribute quality requirements and considerations
Qualifications for quality assurance senior manager
- Ability to accept accountability, demonstrate initiative and work with limited direct supervision
- Provide sound, clear and practical advice to the business
- Ability to interpret instructions within a trust environment
- In-depth knowledge of auditing practices, procedures and principles, including but not limited to the International Institute of Internal Auditing (IIA) and Information Systems Audit and Control Association (ISACA) standards and guidance
- Contributes expert perspective to support development of Global QA strategy
- Minimum 5 years transplant experience, Regulatory background with prior QA/PI experience preferred
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Quality Assurance Senior Manager Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality assurance senior manager. 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 quality assurance senior manager
- Representing the GCP function on various clinical project teams and other working groups, functional areas, and with external partners providing GCP consult and supporting R&D clinical development programs
- Conducting external audits to assess compliance with GCP requirements, investigational plans and Lexicon standards for clinical trial related activities
- Conducting a QA program for related functions as roles of an internal quality audit by scheduling review& report weekly/ monthly/ quarterly/ annually
- Ensure facility and process audits vendor audits are scheduled in advance and reflected in the QA audit calendar
- Manage the CAPA process for the distribution/logistics department by ensuring that non-conformance and other reportable events CAPA reports are recorded, followed-up, tracked and trended
- Acting as Responsible Person for wholesaling according to §52a German Drug Law and acting as the Graduated Plan Officer Quality according to §63a German Drug Law
- Management of product complaints, quality defects, product counterfeits & recalls on local level including the collaboration with the local supervising authorities in cooperation with Regulatory Affairs
- Maintenance, review and further development of local Quality Management system ensuring regular process improvements and adaptation to changing legal environment
- Ensuring that required Quality Agreements with subcontractors are in place and are up to date at any time
- SOP writing on GDP/GMP related tasks and maintenance in controlled environment and proper record retention
Qualifications for quality assurance senior manager
- Experience with successful clearance and/or approval of US FDA medical device submissions
- Minimum of 3 years of experience managing and interacting with contract manufacturers
- Must understand standards of practice for the manufacture of biotechnology products
- Prior end-users training experience is a plus
- Must have excellent quality and compliance mindset to approach issues and present solutions
- Ability to extrapolate from previous experience to identify issues before they become systemic
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Quality Assurance Senior Manager Job Description
Job Description Example
Our company is growing rapidly and is looking for a quality assurance senior manager. 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 senior manager
- Act as subject matter expert in GCP guidelines, regulations and compliance-related issues
- Provide guidance and/or training to Clinical Trial Team personnel, third party vendors and investigators on GCP and SOP/QA-related matters as appropriate
- Lead the team in planning, preparing and executing effective test strategies focused on identified business area(s) and related projects
- Manage relationships with project team members, third party vendors/ service partners, release teams and business stakeholders as appropriate
- Provide insight, information and recommendations on industry trends and significant testing issues
- Conduct regular performance reviews in a timely manner, discussing and assisting employees with their growth and development
- Use risk based methodologies and tools that align with the development approach/methodology selected for the project
- Ensure the test process, methodologies and tools are applied appropriately and that test phase entry/exit criteria are agreed to by stakeholders and applied by the test team
- Communicate and demonstrate a strong understanding of the impact to testing as it relates to scope changes from a timeline/cost and a risk perspective
- Review and provide input to project documentation as required
Qualifications for quality assurance senior manager
- Identifying, writing evaluating and closing Deviations and CAPAs
- Experience with internal and external audit principals
- General knowledge of aseptic manufacturing processes
- Experience with Change Control practices/strategies
- Knowledge of equipment, facility and utility IQ/OQ/PQ/PV
- The Senior Manager will have a BS degree in life sciences, bioengineering, or related field and 5+ years of quality experience in biopharmaceutical or vaccine industry, plus 2 years’ management experience in QA/QC supporting commercial products
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Quality Assurance Senior Manager Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of quality assurance senior manager. 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 senior manager
- Ensuring that a quality management system (QMS) is implemented and maintained, including but not limited to
- Oversee and drive change initiatives
- Support Global Quality Management and R&D partners with hosting and/or facilitating regulatory agency inspections
- Assist the Director, Regulatory Affairs and Quality Assurance with the development, implementation, and strict adherence to a quality assurance program
- Responsible for customer on-site audits and the management of audit responses
- Manage multi-site SOPs
- Schedule and perform quality assurance audits and report findings to the President and Chief Operating Officer
- Review reports and other documentation required by regulatory agencies and to support the quality assurance function
- Supervise tagging and quarantine procedures for rejection of in-process, finished product and component receiving inspection areas
- Prepare and review complaint (quality) trends
Qualifications for quality assurance senior manager
- Broad to in-depth knowledge of FDA regulatory requirements for biologics, especially vaccines or pharmaceuticals
- Superior skills in building and maintaining strong relationships with direct reports multiple internal and external team members across functional groups
- Oversight of assigned QA/QC team, and will oversee/lead non-direct reports from Business Lines (may oversee/manage direct reports)
- Develops QA/QC framework and the annual testing plan for all of Consumer Banking
- Provides monthly summary statistics to the Head of Consumer Bank
- Reviews on a sample basis tests performed by the QA/QC team
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Quality Assurance Senior Manager Job Description
Job Description Example
Our growing company is looking to fill the role of quality assurance senior manager. 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 senior manager
- Develop, review and critique Corporate Quality Procedures (CQP's) and insure full implementation
- Provide leadership to the corporate Quality Systems audit teams as required, and direct team to conduct pre-AIB/BRC facility audits upon request
- Support DMPS initiatives as they relate to quality or food safety objectives, through familiarity with projects and providing information on request
- Through participation on the Northwest and California League of Food Processors Technology Committee, maintain open lines of communication with member company QA groups and stay abreast of new legislation and common issues
- Manage the activities of the region audit lab by providing direction and oversight in the analysis and evaluation of Fruit & Tomato and tomato product samples for self-produced, co-packed, and purchased products
- Ensure Fruit & Tomato finished product specifications and grading matrices are maintained, current, and standardized for all Fruit & Tomato facilities
- Direct and maintain the executive cutting for all DM samples during the production season
- Participate in cuttings to evaluate competitor products and Ag
- Conduct product evaluations of aged stock and non-conforming product, and issue appropriate dispositions as needed
- Direct the Quality Systems group in conducting annual mock recalls at all Fruit & Tomato facilities
Qualifications for quality assurance senior manager
- 13+ years of experience with quality assurance management
- Hands on experience with sterile manufacturing, product development
- Working Knowledge of applicable cGMP regulations (21CFR 211, EU GMP, PIC/s GMP, ICH ) and standards (ISO)
- Strong knowledge of GMP, SOPs, quality systems, and investigations
- Experience in the field of Instrumentation/Engineering an advantage
- Must be able to exercise excellent judgement for decision-making responsibilities