Reports To (Position): Executive Director, Quality and Compliance
Location: South San Francisco, CA
Department Name: Quality Assurance
HR Designations: Pay Status – Exempt
Objective of Position
The Associate Director/Director, Clinical Quality Assurance, supports quality assurance and compliance functions by managing, planning, scheduling, overseeing, and conducting GxP Quality Assurance and Compliance activities.
Essential Duties/ Responsibilities
- Supports/leads the successful implementation and maintenance of an effective quality and compliance program specific for GXP, taking into account ICH guidelines, US, European, and other countries’ requirements.
- Supports the Head of Quality and Compliance in:
- Managing and executing “second line of defense” accountabilities e.g., training and development, support for auditing, investigations, routine assurance reporting, updating procedural documents, etc.).
- Driving and embedding a culture of ethics and integrity.
- Hosts/leads/supports regulatory inspections and business partner audits.
- Ensures the company is always prepared for regulatory inspections and audits by the development of tools and training for functional departments.
- Develop and facilitate GCP/GXP training for functional areas and personal involved in the execution of clinical trials.
- Participate in the evaluation, qualification and selection of CROs and other clinical and nonclinical service providers and support due diligence activities.
- Serve as an expert and provide guidance on and interpretation of GCP/GCLP/GVP regulations, standards and quality systems.
- Participates in quality activities to set and translate overall quality strategy into programs for implementation.
- Leads/supports QA-initiated audit activities, internal and external, including maintenance of audit forms and toolkits as needed.
- Supports creation of QA audit schedule and suggests internal and external audit targets.
- Supports in a timely review of Quality Event and CAPA plans identified via the audit and inspection processes.
- Ensures implementation of procedures and other documents to support successful QA hosting of regulatory inspections, including interview preparation and backroom support.
- Prepares, reviews and delivers presentations regarding GxP Compliance to senior management; initiates or reviews other presentations needed to support quality and compliance activities.
- Presents quality and compliance concerns to Acerta Pharma management, functional areas, and external customers in a professional, collaborative manner.
- Acts as liaison to Acerta Pharma functional groups, working collaboratively to address issues related to GCP/GCLP/GVP issues.
- Performs other activities, as assigned, to support overall organization’s goals and objectives.
- Knowledge of the overall drug development process is required.
- Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing and regulatory inspection is required. Experience with GLP/GCLP/GVP is preferred.
- Adept at problem identification, problem solving and organizational skills is required.
- Ability to work in a dynamic organization with aggressive timelines and multiple deliverables.
- Experience with quality assurance activities in a regulated environment is required.
- Experience with audit reporting and CAPA management is required.
- Experience with conducting investigation, root cause analysis, and CAPAs, specifically in the context of GCP regulatory inspection and audit responses is required.
- Experience in applying organizational policy or procedures to a variety of situations is required.
- Adept in training and implementing procedures compliant with FDA/EMA/ICH/WHO guidance and regulations is required.
- Minimum of 8 years of experience in supporting and conducting clinical quality and compliance activities and vendor audits is required.
- Experience in leading audits and sponsor regulatory inspections is required.
- Experience in drafting responses and implementing corrective and preventive actions to address audit and inspection observations is required.
- Experience in Part 11 computer system validation activity specific to configuration management and UAT is preferred.
- Excellent verbal and written communication skills.
- Demonstrated skill in supervising quality and compliance personnel and project management.
- BS or MS degree in Clinical or Scientific discipline preferred.
- Minimum 12 years of pharmaceutical industry experience, with at least 8 years of clinical quality assurance experience.
- Proficient in Microsoft Office applications (e.g., Word, Excel and PowerPoint).
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 construed 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.