Associate Director, GCP and PV Regulatory Compliance

Company: Ascendis Pharma Inc.
Location: Palo Alto
Posted on: February 25, 2021

Job Description:

Associate Director, GCP and PV Regulatory Compliance Development Operations Palo Alto, California, United States Full time The Associate Director, GCP and PV Regulatory Compliance will be based in Palo Alto and will report directly to the Senior Director, GCP and PV Regulatory Compliance. The Associate Director, GCP and PV Regulatory Compliance is responsible for oversight of the compliance, quality, standards and training for the Global Development and Development Operations, including the PV organizations. Establishes and executes global GCP and PV processes, standards, and compliance monitoring systems. Also responsible for ensuring compliance with all Corporate policies, global regulations and guidelines and internal procedures within Development Operations and Global PV. Ensures GCP and PV Inspection Readiness and continuous process improvement. Requires a proven ability to strategically make and be accountable for decisions to meet the ever growing and changing stringent global GCP requirements. Key Responsibilities --- Collaborates with internal and external stakeholders to ensure appropriate GCP and PV systems are implemented and maintained. --- Reviews and analyzes audit, inspection and CAPA data to identify compliance trends and areas of exposure related to pharmacovigilance. --- Provides expert compliance advice on GCP and PV strategies, programs, processes, initiatives, and activities to help manage and mitigate risk. --- Collaborates, liaises and supports all Ascendis functional groups contributing to the PSMF to ensure they provide the required information on time for the PSMF update. --- Periodically reviews existing Standard Operating Procedures (SOPs) relative to Development Operations and the pharmacovigilance function within Ascendis to determine the need for changes and updates of existing documents and the initiation of new procedural documents. --- Leads subject matter experts in the modification of current SOPs and in the initiation and development of new procedures. --- Provides inspection readiness activities including but not limited to monitoring for noncompliance and ensuring responsible functions mitigate risks. --- Collaborates with QA Training to conduct inspection readiness training, one-one practice sessions and mock audits as needed. --- Assesses impact of changes in new GCP and PV regulations and guidance on current practices and processes and coordinate with other functions for updates as needed. --- Serves as the lead PV representative on SOP and process committees within Ascendis. --- Partners with the Global Quality Assurance and Compliance teams to determine GCP and PV best practices for Ascendis and drive implementation of PV standards across the Global Clinical Development and Development Operations organizations. --- Responsible for the preparation of periodic metric reports depicting non-compliance with internal procedures; and the review, monitoring and trending root cause analyses for non-compliance metrics. --- Collaborates with subject matter experts and senior management to formulate responses to audit/inspection findings relevant to GCP and PV issues. --- Reviews records of internal and external audit deficiencies to identify gaps, conduct non-compliance investigations and communicate with functional heads in preparing, prioritizing and monitoring the mitigation schedule. Requirements --- Bachelor of Science Degree required; graduate degree in a scientific discipline or Healthcare profession desirable --- Extensive experience in quality systems, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs --- Minimum of 8-10 years in the pharmaceutical industry with significant experience in GCP and/or Pharmacovigilance, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities worldwide. --- Experience in the development and maintenance of compliance monitoring and GCP/pharmacovigilance SOPs and another process-related documents --- Analysis and decision-making based on sound risk-based judgment --- Effective interpersonal skills to insure various type of inter-departmental team relationships --- Excellent communication skills for oral and written presentations, communications and documents --- Understanding of a large-scale electronic data storage and retrieval systems --- Requires strong attention to detail in establishing priorities, scheduling and meeting deadlines --- Excellent interpersonal, communication, analytical, and organizational skills --- Ability to travel up to 20% of the time domestically and internationally Ascendis Pharma collects and processes personal data in accordance with applicable data protection laws. If you are a European Job Applicant see the privacy notice for further details. Ascendis Pharma is proud to be an equal opportunity workplace and we believe that diversity and inclusion among our workforce is critical to our success as a global company. Individuals seeking employment at Ascendis Pharma are considered without regards to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. All employment is decided on the basis of qualifications, merit and business need.

Keywords: Ascendis Pharma Inc., Palo Alto , Associate Director, GCP and PV Regulatory Compliance, Executive , Palo Alto, California