Associate Director, Quality Assurance Job Description
Associate director, quality assurance
provides GCP, GVP QA advice to Clinical Operations and Development, Nonclinical Safety, Drug Safety and Pharmacovigilance based on interpretation of current regulations to assure best practices.
Associate Director, Quality Assurance Duties & Responsibilities
To write an effective associate director, quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included associate director, quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Represents Research Quality Assurance in cross-functional project settings
Has responsibility for Quality assurance and control functions to include direct support to EP’s, coordination and oversight for product testing, other relevant components as determined by applied calibrated Quality oversight
Manages team of Quality Assurance professions as direct reports
Provide Quality Assurance input for troubleshooting, failure analysis and problem solving activities related to intermediate, DS and DP manufacturing or testing
Represent Quality Assurance at meetings and assure compliance of agreements with CMOs, specifically, CMOs are compliant with both Dynavax and regulatory standards
Develop, implement, manage and report on continual internal audit and testing of all Title IV process outcomes
Expert in interpretation of federal statutory and regulatory guidelines and act as a resource for internal clarification
Ensure the Institute is in compliance with all required consumer information disclosures
Assist in presentations in compliance topics and in development and execution of a training manual including the annual training of the student financial services management and staff
Communicate audit findings and monitor Pharmacovigilance compliance to regulations and
Associate Director, Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate Director, Quality Assurance
List any licenses or certifications required by the position: ASQ, HEPA
Education for Associate Director, Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the associate director, quality assurance 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, Chemistry, Technical, Education, Biology, Life Sciences, Pharmacy, Microbiology, Sciences
Skills for Associate Director, Quality Assurance
Desired skills for associate director, quality assurance include:
Drug development process
Applicable regulations
Quality Assurance
Regulations and auditing
FDA regulations
GCP/PV guidelines
Multiple therapeutic areas and nonclinical study conduct
Biologics and pharmaceutical products
CGxPs
EU regulations
Desired experience for associate director, quality assurance includes:
Provide pertinent quality metrics to senior management and key stakeholders
Prepare and host Regulatory Agency inspections as appropriate
Provide consultation on quality and compliance to the Pharmacovigilance function
Evaluate Pharmacovigilance Quality System and processes for optimization and continuous improvement
May provide Compliance training to Pharmacovigilance teams and vendors
Establish and maintain a risk-based and scientific-based quality system to support Good Clinical Practice
Associate Director, Quality Assurance Examples
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Associate Director, Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is looking for an associate director, quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate director, quality assurance
- Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are conducted and reports written according to SOPs and regulations
- Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity
- Supports strategic direction with cross functional working groups to identify and mitigate GCP/GLP quality and compliance issues
- Supports the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality
- Provide support and coaching to other staff members to develop additional quality and auditing resources
- Designs and executes robust, risk-based internal and external GCP audit programs
- Assists with execution of GVP and GLP audit programs
- Leads inspection readiness activities and supports regulatory inspection hosting
- Selects and supervises external consultants and auditors
- Responsible for escalation of significant quality deficiencies
Qualifications for associate director, quality assurance
- Designs, collects and report quality metrics
- Assists in the preparation and review of regulatory submissions for global health authorities
- Lives the Ironwood Core Values of Ownership, Collaboration, Innovation, Excellence, Humanity, and Fun
- Thorough working knowledge pharmaceutical/biotech GCP regulatory requirements (US and ex-US)
- Previous participation in regulatory agency inspections
- Experience communicating with both domestic and international collaborators with an awareness of cultural diversity
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Associate Director, Quality Assurance Job Description
Job Description Example
Our growing company is looking to fill the role of associate director, quality assurance. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate director, quality assurance
- Provides Quality insight/feedback to internal departments
- Determine appropriate action plans and obtain buy-in from functional areas on remediation activities and dates
- Ensure the compliance of Ionis’ manufacturing and testing activities with respect to Ionis’ procedures FDA, EMA, Health Canada, MHLW, and ICH, and other regulatory expectations and requirements
- Perform batch and test record review and lot disposition activities for intermediates, DS and DP
- Provide quality oversight of contract DP manufacturing and testing and for providing decision-making during formulation and sterile filling activities
- Resolve moderately complex deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, or any other quality events as directed by area management
- Perform internal audits of Ionis’ cGMP operations and perform external audits of Ionis’ suppliers, as necessary
- Support conduct of partner and regulatory audits and inspections
- Coordinate, prepare, and manage CMC (Quality) documentation for NDA/BLA/MAA submissions and subsequent variations/supplements
- Support Annual Product Quality Reviews (PQR) for assigned projects by consolidation/ summarization of internal and contractor data
Qualifications for associate director, quality assurance
- Strong organizational and interpersonal skills, and the ability to build positive relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving
- Ability to work both independently and collaboratively to manage multiple tasks in a fast-paced, fluid working environment
- B.S or M.S Degree in a relevant field
- Ability to travel by car and plane
- Expertise in specific compliance disciplines (AWP/GLP/GCP/GCLP/Non Regulated/PV/IT/QMS)
- Bachelor’s Degree in a relevant discipline (e.g., chemistry, biological sciences, engineering)
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Associate Director, Quality Assurance Job Description
Job Description Example
Our growing company is hiring for an associate director, quality assurance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate director, quality assurance
- Develops, implements and directs operating procedures for the Devens Clinical Manufacturing (DCM) quality assurance program which assures effective shop- floor quality presence
- Keep abreast of industry trends with respect to CMC regulatory policies and procedures within the EU, US, and ROW
- Develop risk based and current industry standard annual audit planning focusing on
- Schedule, personally conduct and/or manage quality audits for GPvP activities (and PDMA activities a plus)
- Assist in vendor selection, oversight and risk based auditing of 3rd parties supporting GPvP
- Build and manage internal and external resources for quality audits and ongoing departmental oversight and partnerships
- Key Opinion Leader for GPvP and PDMA regulations, process strategies and regulatory guidance’s (domestic & international) for all related departments
- Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance and inspection readiness (ie Pre-Clinical, Clinical Development, Drug Safety, Medical Affairs, Regulatory Affairs and Sales & Marketing)
- Provide oversight for and participate in audits of
- Provide management oversight for and participate in internal systems audits relevant to safety data and sample management
Qualifications for associate director, quality assurance
- Specifically in PV auditing
- Cutting edge knowledge of GVP, government regulations and guidelines ( EMA, FDA, PMDA)
- Pertaining to Pharmacovigilance
- Solid knowledge of IT structure and Information Database Systems (such as Oracle Argus
- Ability to travel 30 to 40% (domestic and international)
- Proficient in FDA, EMA, Health Canada, MHLW and ICH regulatory requirements and guidelines related to cGMP operations
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Associate Director, Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is looking for an associate director, quality assurance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate director, quality assurance
- Provide management oversight and collaborate with the Drug Safety group in follow-up to internal, vendor, specialty pharmacy and partner audits to ensure resolution of audit findings
- When requested provide global GPvP training for internal staff
- Lead the preparation and conduct of mock and regulatory agency inspections and report responses
- Provide operational oversight for quality business systems
- Manage projects related to new quality initiatives or company-wide projects requiring significant QA support
- Undertake regular reviews of the donor landscape in Angola and ensure WV is pre-positioned in strategic areas
- Together with the required technical specialists & project managers, develop programme concepts in support of the NO strategy
- Mobilize resources to support the implementation of the NO Strategy and advance child wellbeing outcomes and maintain a balanced portfolio for WV Angola
- Lead proposal development processes, coordinating bid teams and ensuring WV Angola prioritizes strategic funding opportunities when necessary
- Develop effective relations and ensure high-quality working relationships with external stakeholders such as, NGOs, IOs, UN agencies, and current and potential donor representatives both within country and at Support Offices, to ensure adequate funding and to raise WV’s profile
Qualifications for associate director, quality assurance
- Able to manage multiple priorities with aggressive timelines at a high level of productivity in an intense work environment
- Minimum 9 years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP QA experience
- Minimum 5 years managing teams in a matrix team environment or managing people
- Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidances and Computer System Validation
- In-depth knowledge of drug development processes and GCP regulations
- Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity
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Associate Director, Quality Assurance Job Description
Job Description Example
Our innovative and growing company is hiring for an associate director, quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate director, quality assurance
- Assures that the partner operates within the agreed upon GMP policies and procedures (or other applicable regulations) and in accordance with the Quality elements of the Commercial Agreement and the Quality Agreement
- Plan and execute training programs to both internal GIA members and co-sourcing partners
- Identify global audit or risk trends by maintaining a thorough and vast knowledge and understanding of audit issues and industry updates through consulting with industry counterparts and experts, attending training courses, continuing education
- Generate monthly productivity, quality, and resource usage statistics
- Review/approve critical GxP controlled documents , master and executed batch records, test methods, specifications, change controls, deviations, CAPA, laboratory investigation, design control, drawings and other documents as applicable
- Coordinate customer complaint investigations of Japan customers
- Coordinate any field corrections and removals in Japan
- Scope includes materials and products utilized / manufactured in the Devens Clinical Manufacturing (DCM) / single-use manufacturing facility, which produces products across a broad scope of lifecycle stages
- Directs the DCM quality oversight of start-up and technology transfer activities including approval of batch records and associated process documentation
- Directs the DCM QA support for ongoing validation activities for equipment, cleaning, sterilization, and process qualification and validation
Qualifications for associate director, quality assurance
- Requires established ability to manage and implement multiple projects/tasks simultaneously with competing priorities
- Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments
- Must be capable of effectively working with all levels of the organization
- In coordination with internal customer needs, ensuring the required data quality and compliance training is established and provided to the the external service providers and research organizations
- Requirements include minimum bachelor’s degree in nursing, pharmacy or allied health/science
- 15 years pharmaceutical industry experience within the Quality/Compliance Oversight of