Associate Director, GCP and Pharmacovigilance Regulatory Compliance
Company: Ascendis Pharma Inc.
Location: Palo Alto
Posted on: May 3, 2021
Associate Director, GCP and Pharmacovigilance Regulatory
Development Operations, GCP and Pharmacovigilance Regulatory
Compliance Palo Alto, California, United States Full time
Ascendis Pharma is looking to hire a passionate Associate Director
who will report to the Senior Director, GCP and PV Regulatory
Compliance. The Associate Director is a working member of the
Development Operations and Quality Assurance team focused on the
delivery of PV and clinical quality services to the company. The
Associate Director also acts in place of the Sr. Director in times
of need. This is an exciting opportunity to join a rapidly growing,
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
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
Provides expert compliance advice on GCP and PV strategies,
programs, processes, initiatives, and activities to help manage and
Has oversight of 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
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
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
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
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.
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 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
Experience in the development and maintenance of compliance
monitoring and GCP/pharmacovigilance SOPs and another
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
Requires strong attention to detail in establishing priorities,
scheduling and meeting deadlines
Excellent interpersonal, communication, analytical, and
Ability to travel up to 20% of the time domestically and
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 Pharmacovigilance Regulatory Compliance, Other , Palo Alto, California
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