What are the responsibilities and job description for the Executive Director, GCP, GLP and GVP Quality position at Ardelyx?
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
Reporting to the Senior Vice President of Quality, the Executive Director of GCP, GLP and GVP Quality will be a key role on the Quality Leadership Team directing all aspects of Clinical (GCP), Good Laboratory Practice (GLP), and Pharmacovigilance (PV) Quality for pre- and post-marketed products. This position will manage the development of risk assessments, audit programs, and planning and resourcing audits. In addition, this role will lead or partner with colleagues to prepare Ardelyx for GCP/GLP/PV regulatory inspections. Other responsibilities include the provision of regulatory compliance and QA guidance to clinical and drug safety teams, review and provision of QA input into the related policies and procedures and lead training efforts for SOP and regulatory topics in the scope of responsibilities based on needs analysis.
Responsibilities:
- Develop, implement, and maintain QA GCP/GLP/PV systems, risk management processes, and associated Policies and SOPs
- Provide updates and strategic recommendations to the executive leadership team relating to GCP, GLP and GVP quality oversight and compliance
- Ensure compliance of clinical development activities to applicable quality and regulatory requirements.
- Present Quality metrics on GCP/GLP/PV aspects of all development and marketed programs at Quality Management Review meetings and provide recommendations for continuous improvement
- Ensure a risk-based approach to the identification and management of Quality issues
- Ensure suitability of corrective and preventive actions, verifying CAPAs to completion and keeping management informed of CAPA metrics
- Sponsor initiatives to ensure continuous improvement of QA systems
- Develop and maintain an audit program for clinical sites, CROs, and contract laboratories
- Review of GLP and GCP study protocols and reports, clinical study reports, external publications, regulatory submissions, etc.
- Oversee the PV audit program and PV inspections and ensure inspection readiness
- Collaborate with Ardelyx international partners as needed
- Develop budget forecasts and track QA expenses
Qualifications:
- Bachelor’s degree with 15 years of related experience preferably in life sciences with 8 years of experience in GCP/GLP Quality and PV Quality related roles or equivalent experience
- Must have strong expertise in international GLP/GCP/PV regulations and guidance with a strong emphasis on compliance and direct experience with regulatory submissions
- Must have direct experience with hosting, leading and managing US and international inspections
- Proven ability to identify Quality issues/discrepancies through a risk-based approach and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner
- Regulations, 21CFE Part 11, ICH-GCP, HIPAA/data privacy
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment
- Must have strong written and communication skills
- Ability to travel domestically and internationally up to 20%
The anticipated annualized base pay range for this full-time position is $269,000-$329,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Salary : $269,000 - $329,000
