- Leads direct reports including management of internal staff and/or consultants.
- Performs and oversees the implementation of a vendor qualification program that includes a sponsor oversight plan to meet the company's business requirements related to quality, expertise, cost, cybersecurity, deliverables, and timelines.
- Performs and oversees the implementation and effectiveness of the GCP/GVP quality oversight and audit program in assuring quality risk management/mitigation, including performing GCP audits of internal processes, vendors and clinical trial sites.
- Reviews and analyzes audit, inspection and CAPA data to identify compliance trends and areas of exposure related to GCP/GVP.
- Acts as Quality partners with internal and external stakeholders to determine best practices for Ascendis and provide expert advice/consultancy on complex topics.
- Experts in the modification of current SOPs and in the initiation and development of new procedures.
- Periodically reviews existing Standard Operating Procedures (SOPs) relative to GxP related functions within Ascendis.
- Assesses impact of changes in new GCP and GVP regulations and guidance on current practices and processes and coordinates with other functions for updates as needed.
- Leads and supports inspection readiness activities including but not limited to monitoring for noncompliance and ensuring responsible functions mitigate risks.
- Collaborates with QA Training department to conduct inspection readiness training, one-one practice sessions and mock inspections as needed.
- Hosts or supports GCP & GVP health authority inspections including planning, conduct and follow-up.
- Collaborates with subject matter experts and senior management to formulate responses to audit/inspection findings relevant to GCP and GVP.
- Responsible for the establishment and analysis of KPI/KQIs including periodic reporting, review, and trending.
- Independently leads cross-collaborative quality initiatives.
- Promotes Quality Culture within Ascendis.
- Salary range: $220-235K/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance
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Director GCP - Palo Alto, CA, United States - Ascendis Pharma A/S
Description
Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.
We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.
We promote a trusting and appreciative company culture and value colleagues of diverse backgrounds and their abilities to contribute unique viewpoints and perspectives to all aspects of the business, from drug development to marketing.
This position is based in the US. The Director, GCP & GVP Quality is responsible for the management of direct reports and for the oversight of the compliance, quality, standards and training within the Good Clinical Practice and Pharmacovigilance (GCP/GVP) areas, with an emphasis on GCP.
Responsible for the execution of a proactive, risk-based Quality Strategy, and maintenance of vendor qualification, global GCP and GVP processes, standards, and compliance monitoring systems.
Responsible for performing GCP internal, vendor, and clinical trial site audits.
Ensures GCP and GVP 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/GVP requirements.
Key Responsibilities
