Director, Assurance Job Description
Director, Assurance Duties & Responsibilities
To write an effective director, assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included director, assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Director, Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, Assurance
List any licenses or certifications required by the position: CPA, ISO, ASQ, GIAC, CISSP, CLIA, AS9100, 9001, GCIH, GCIA
Education for Director, Assurance
Typically a job would require a certain level of education.
Employers hiring for the director, assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Accounting, Engineering, Science, Education, Technical, Business, Management, Computer Science, Finance, Chemistry
Skills for Director, Assurance
Desired skills for director, assurance include:
Desired experience for director, assurance includes:
Director, Assurance Examples
Director, Assurance Job Description
- Defines and implements quality standards, systems, and metrics for clinical and commercial drug product operations
- Keep the Partner informed on a timely basis as to all important engagement developments
- Review the control environment and quality of procedures and client documentation in place, including, SLA’s, Op Memo’s and contracts
- Scheduled/unscheduled NDI inspections, and draft QA related Naval messages identified in the CNAFINST 4790.2 Series
- QAR’s will notify the Government Oversight QAR’s of all Flight Critical, Safety of Flight, and mandatory QA inspections, including FCF Briefs / Debriefs
- Ensure contractor QA personnel are present on the hangar bay for all maintenance requiring hydraulic power on aircraft
- Ensure all QAR’s assigned to the contractor maximize maintainer interaction and hangar deck/flight line supervision (defined as >50% of working day), observing and inspecting during maintenance evolutions
- Perform or delegate hourly verification of “in-work” or “out-of-work” status on aircraft with NALCOMIS status of same maintenance
- Interacts with pertinent internal departments
- Directs activities associated with Environmental Monitoring Process Qualifications for new facilities, existing facilities, to both US and EU requirements
- Experience working with Security Frameworks ISO 27001, NIST 800-53, CSA CCM
- Direct involvement in implementing and improving an Agile Development methodology in organizations
- BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred
- Prior experience servicing clients in the public sector industry preferred
- Bachelor’s degree in an Engineering discipline or related technical field and (14) fourteen years of progressively responsible directly related experience, or an equivalent combination of education and experience
- Strong technical acumen and broad engineering and critical thinking skills
Director, Assurance Job Description
- Ensures integrity of audit policy and procedures including implementation of corrective action plans
- Quality criteria include accuracy, timeliness, compliance with company standards, regulatory requirements, and customer agreements
- Leads auditors to analyze trends, make recommendations and initiate corrective action with vendors and/or internal business units
- Initiates and executes special projects to identify business unit issues, deficiencies and opportunities for improvement
- Ensures regulatory observations are adequately addressed and completed on schedule
- Partners with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains and interfaces with customer/partner quality organizations
- Represents Quality on cross functional teams
- Partner with Supply Chain and External Manufacturing to assure quality requirements are met for development and commercialization activities occurring at CMOs and partners
- Responsible for recruiting and training of personnel in the group
- Manages Department personnel by developing work plans, establishing objectives, and assigning tasks
- Experience working with Healthcare Institutions preferred
- Minimum of 10 years of increasing responsibility managing quality assurance teams using agile best practices
- Ability to work collaboratively across functional boundaries to drive high quality results
- Prefer candidates with current Director level experienced that have managed Sr./ Managers
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, change management, design verification and validation activities
- A Bachelor of Science in Computer Science / Electrical Engineering or equivalent experience is required
Director, Assurance Job Description
- Oversee business compliance to the Group risk management strategy
- He/she will serve as the global technical leader in the areas of sterilization, aseptic processing and microbiology with responsibility for all Global Surgery locations worldwide
- This individual will be responsible for defining company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, pure water systems and related areas
- The Senior Director, Sterility Assurance will work with the Make organization to establish long-range sterilization strategies for Global Surgery products
- He/she will have managerial responsibility for Global Surgery Sterility Assurance functions
- Support new product development, collaborating with Product Development and suppliers to provide design inputs to validate sterile and microbiologically controlled products
- This individual’s duty will also include working with Supply Chain to establish, validate and maintain clean manufacturing environments, processes and utilities
- The Senior Director, Sterility Assurance will interact with external regulators and various levels of company management, working across many functional areas
- He/she will influence the company’s strategic and tactical directions and financial results globally through the application of technical leadership, knowledge and expertise
- The Senior Director, Sterility Assurance will assure that Global Surgery programs are aligned with the overall J&J Sterility Assurance programs
- Solid understanding and expertise in SOA, DevOps and TestOps principles
- Design and implement quality process, and quality metrics for cloud based application
- Analyze changes and new features to the product based on functional and design requirements, recommending appropriate test strategies
- Good leadership skills to allocate and manage work of other team members
- Develop test plans and specifications and implement/code test cases in Java
- Drive product testability into product requirements
Director, Assurance Job Description
- Develop strong partnerships with key stakeholders to ensure successful delivery of software products and solutions to meet key business objectives
- Oversee the implementation and ongoing compliance with appropriate quality management systems including ISO27001, ensuring that all systems, processes and procedures are documented, version controlled and contractually compliant
- Plan, review, recommend and implement health and safety management systems and practices across the organisation in line with prevailing legislation
- Develop a programme of fraud and anti-corruption measures for all employees, stakeholders and subjects proactively seeking weaknesses in the control environment and dealing with investigations in the event of a potential issue
- Work closely with the Infosec team to ensure appropriate alignment
- Ensure that all work is delivered within the budgetary and resource constraints of the organisation
- Directs the sustainability and improvement of AAG's Safety Management System (SMS) and the Aviation Safety Action Program (ASAP)
- Leads and facilitates cross-divisional safety risk management (SRM) reviews
- Advises and supports cross-divisional safety management system (SMS) executive safety review boards (ESRB), safety review boards (SRB), and division analysis groups (DAG) with key enterprise safety performance metrics
- Maintains a strong and transparent relationship with the FAA on SMS performance
- This is a critical role within the Compliance department
- Test Frameworks and tools xUnit, Selenium, Sikuli, Mocha
- TDD, BDD and tools SpecFlow, Cucumber
- 7+ year of relevant leadership work experience in Finance Operations, Payments and/or Settlements
- An undergraduate (BS) degree with Microbiology, Biology, Engineering or related discipline is required
- Bachelor’s degree in quality assurance, operations management or related discipline
Director, Assurance Job Description
- Ensure the Quality organization is a full partner in driving company / site initiatives and improving business operations performance
- Establish and drive Quality initiatives that advance improvement in both delivery and cost, while aligned to Corporate Core Value Drivers and Business Unit / OpCo level KPIs
- Drive the development of Quality Assurance policies, procedures, standards and strategies
- Oversees all auditing activities to include internal, customer, and vendor audits in accordance with the established audit schedule or equivalent and applicable organizational processes
- Manage and enable high-functioning operational quality assurance and quality engineering teams which continuously contribute to the improvement of company’s Quality Management System processes, including assuring quality and customer standards and appropriate final product dispositions, managing company’s validation activities, training, and feedback processes
- Mature relationships with our contractors in area of responsibility
- Resolve bottlenecks related to key changes and batch disposition
- Own GMP materials relating to area of responsibility
- Oversees calibration and testing of programs
- Actively interface with customers to promote positive, constructive relationships
- Superior organization, prioritization and planning skills with ability to manage multiple projects simultaneously
- Six Sigma Black/Green Belt certified or trained preferred, and knowledge of lean manufacturing
- Must be a self-starter, able to work autonomously, and motivate the team to ensure timely achievement of objectives
- Program Leadership
- A minimum of a bachelor’s degree preferably in pharmaceutical sciences with 12+ years in a pharmaceutical/biotechnology industry with at least 10+ years in Quality Assurance
- Computer science or related field with 5+ years of relevant management experience and at least 3+ years of experience as a people manager leading teams