Associate Director, Quality GcP/GvP

Karyopharm Therapeutics

Karyopharm Therapeutics

Quality Assurance
United States · Remote
Posted on Thursday, July 11, 2024

Associate Director, Quality GcP/GvP

Job Locations US-Remote
Job ID
2024-2284
# of Openings
1
Category
Research and Development
Type
Regular Full-Time

Role Overview & Key Functions:

Provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPVP) to ensure continuous inspection readiness in planning, execution, and post-completion of the studies, and ongoing Pharmacovigilance support throughout marketed products’ life cycles.

  • Maintain expertise in applicable regulations, guidelines, and industry trends related to GCP/GPVP to provide leadership, guidance, and mentorship to stakeholder teams.
  • Conduct Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), Clinical Protocols, Informed Consent Forms (ICF), etc..
  • Assist QCC Leadership during regulatory authorities and auditors during inspections and audits, and ensure timely, relevant, and accurate corporate responses to queries and/or findings. Assist stakeholder teams with development and maintenance of relevant self-inspection practices and inspection-readiness materials.
  • In consultation with stakeholder teams, establish & monitor KRIs/KPIs for enterprise compliance with applicable regulatory GCP/GPVP requirements and internal procedures.
  • Develop and deliver training programs on GCP/GPVP quality/compliance to enhance staff knowledge and promote best practices.
  • May participate as standing SME member in clinical, regulatory SME on team reviews of programs, processes, procedures, and represent Karyopharm’s GCP/GPVP compliance expectations with external partners, including CROs, vendors, and clinical sites.
  • As needed, provide or support SME assistance to PV and Clinical Operations teams to investigate and resolve quality/compliance issues, including development of meaningful CAPA plans; as appropriate, escalate critical issues to the senior leadership.
  • Assist GxP Audit team in prioritization and execution of GCP/GPVP audit planning, preparation, performance, and follow-up.
  • Participate in QA Review of Internal SOPs, driving toward establishing and maintaining harmonized and cross-functional SOPs.
  • Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.)

Candidate Profile & Requirements:

  • BA/BS degree or in a life science discipline. Advanced degree is strongly preferred.
  • Min of 8 yrs experience in quality assurance and compliance roles within the biotech, pharmaceutical, or CRO industry, with a focus on GCP/GPVP.
  • Strong knowledge of current GPVP regulations, standards, guidelines, and industry-standard expectations.
  • In-depth knowledge of international regulations and guidelines related to clinical trials (e.g., FDA, EMA, ICH) and pharmacovigilance (e.g., EudraVigilance, FDA PV regulations).
  • Excellent understanding of the drug development process and clinical trial operations.
  • Proven track record of successful management of quality assurance and compliance programs, including participation in audits and/or inspections, and investigating and addressing non-compliance issues
  • Strong communication and interpersonal skills, capable of effectively collaborating with cross-functional teams and external stakeholders.
  • Strong problem-solving and decision-making abilities, with a focus on continuous improvement.
  • Experience in inspection readiness exercises and supporting health authority inspections is preferred.
  • Relevant certifications for GPVP and GCP are desirable but not mandatory.

Our Value Proposition:

Boundless Opportunity. Work Fit for Life.

At Karyopharm, we live and demonstrate our ICARE values every day!

If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us – whether that’s onsite, from home, or anywhere in between. What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

Check out our Culture Video!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), teamembers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

  • A culture of employee engagement, diversity, and inclusion
  • Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
  • Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement.
  • Wellness Program with a monthly stipend.
  • Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
  • Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
  • Cell phone allowance

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