Associate Director, GCP and PV Regulatory Compliance
Company: Ascendis Pharma Inc.
Location: Palo Alto
Posted on: February 25, 2021
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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
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