Associate Director, Clinical Quality Assurance
Location: South San Francisco, CA
Department Name: Clinical Quality Assurance
HR Designations: Pay Status – Exempt
Objective of Position
The Associate Director, Clinical Quality Assurance (CQA) supports the CQA function by managing the planning, scheduling and conduct of CQA-initiated audits; assisting CQA team with preparation for regulatory inspections; assisting Senior Director, CQA, with management of Quality Events (QEs) and Corrective and Preventive Actions (CAPAs); providing guidance for Acerta Pharma staff in interpreting clinical development regulations, Good Clinical Practice (GCP) guidelines, and Good Laboratory Practice (GLP) regulations. This position supports a culture of compliance and excellence by working collaboratively with business partners, departments, study management teams (SMTs), vendors to create a team environment that addresses compliance-related issues and corrective actions.
Essential Duties/ Responsibilities
- Supports the internal and external GCP / GLP / Lab GCP / GVP audit program assuring compliance with Acerta Pharma and AstraZeneca Standard Operating Procedures (SOPs), FDA regulations, EMA Directives, ICH guidelines, and relevant local and regional regulatory standards.
- Provides responsive and proactive quality and compliance advice to defined customers and effectively influence assigned area by being relevant GLP expert, as well as lab GCP, HBS (Human Biological Samples) and GLS (Global Laboratory Standard) as required; drives a culture that seeks to prevent non-compliance and poor quality.
- Plans, leads, conducts and reports audit activities for GxP risk-based audit programs.
- Maintains all audit plans, schedules, records, templates, forms and toolkits.
- Acts as primary point of contact with external audit vendors in the planning, execution and reporting of assigned audits. Provides initial review of contracted audit reports and forwards to CQA management for final review.
- Management of CAPAs related to audit and/or inspection findings as well as quality events in collaboration with relevant Acerta and AstraZeneca functional stakeholders.
- Assists with the identification of quality trends, developing and maintaining metrics gathered from audit observations, reported issues and other sources.
- Prepares and delivers presentations and audit results after review by CQA management.
- Acts as CQA liaison to one or more Acerta Pharma and AstraZeneca functional groups and Study Management Teams (SMTs), working collaboratively to address issues related to GCP / GLP / Lab GCP / GVP issues.
- Assists Senior Director with preparation for and execution of regulatory inspections, including backroom support, scribing and related responsibilities.
- Presents quality and compliance concerns to Acerta Pharma and AstraZeneca management, functional areas, and external customers in a professional, collaborative manner.
- Acts as CQA liaison to one or more Acerta Pharma and AstraZeneca functional groups and Study Management Teams (SMTs), working collaboratively to address issues related to GCP/GLP/Lab GCP/GVP issues.
- Performs other activities, as assigned, to support overall organization’s goals and objectives.
- Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing support and regulatory inspection preparation.
- Strong knowledge of GLP (21 CFR part 58) regulations and OECD GLP guidances.
- Minimum of 6 years of experience in regulated pharmaceutical environment.
- Minimum of 4 years of experience in supporting clinical compliance and conducting GxP audits of clinical investigators, facilities, and vendors.
- Experience in drafting responses and implementing corrective and preventive actions to address audit and inspection observations.
- Adept at problem identification, problem solving and organizational skills.
- Excellent command of English language verbal and written communication skills.
- Ability to work in a dynamic organization with aggressive timelines and multiple deliverables.
- Experience in applying organizational policies or procedures to a variety of situations.
- Experience in supporting sponsor regulatory inspections preferred.
- Travel expected.
- BS or MS degree (clinical or scientific discipline preferred).
- Proficient in Microsoft Office applications (Outlook, Word, Excel and PowerPoint).
- Additional training in GxP auditing and computer system validation (CSV) preferred.
To apply for this position, please send your resume to email@example.com
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
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