Associate Director, Quality Systems Technology

Описание вакансии

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.

In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).

Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.

What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.

The Corcept Quality Systems Technology (QST) leader will have primary responsibility for evaluating Veeva Quality software projects and prioritizing the most critical projects for the QA department and Corcept. This role requires a strategic thinker who partners cross-functionally to achieve shared objectives, prioritizes and justifies software projects to meet objectives, and sets clear direction to get there. The leader should be comfortable leading complex system projects, support validation tasks as needed, and directly manage project execution while maintaining strategic oversight. 

The leader should demonstrate the ability to translate business growth and rising complexity into a coherent software strategy, including a 2-year strategic framework that supports sustained growth and organizational maturity. Projects include new implementations, software enhancements, and other continual process improvements. 

The role will support all of Corcept’s quality and GxP operations, leading cross-functional collaboration across teams with diverse and opposing priorities and aligning on the best path forward to achieve high-impact outcomes. Because QST supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.  

This is a hybrid role that typically requires on-site presence three days per week.

Responsibilities: 

• Align QST objectives with departmental and corporate expansion growth goals, ensuring projects deliver measurable business value
• Partner cross-functionally to deliver phase-appropriate solutions that strengthen Corcept’s quality management system and meet business needs
• Evaluate, prioritize and successfully deliver scalable software solutions that support GxP-compliant operations, ongoing enhancements, and day-to-day operations
• Exercise sound judgment in balancing GMP and GCP considerations to meet regulatory and operational requirements
• Balance competing priorities and compliance risks, while maintaining project momentum
• Serve as Subject Matter Expert (SME) for Veeva Quality in regulatory inspections by proactively identifying compliance risks, implementing corrective actions or mitigations
• Lead, coach, and develop the Quality Systems team by setting goals, identifying development opportunities, and assisting in individual career development and growth
• Partner with teams to manage vendor relationships, agreements, and user licenses to scale with Corcept’s expanding footprint and evolving software needs

Required Skills, Qualifications, and Technical Proficiencies: 

• Demonstrated ability to navigate ambiguity and set direction
• Proven leadership skills in a cross-functional role
• Guide and develop team members
• Excellent problem-solving and meeting facilitation skills
• Excellent written and oral communication skills
• Working knowledge of Veeva Quality, LMS systems
• Ability to influence others at various levels of the organization
• Previous hands-on configuration experience is a plus
• Direct involvement and experience with regulatory inspections and audits
• Vendor evaluation and selection process
• Working knowledge of principles for software validation, CSA, GAMP5
• Experienced and well-versed in System Development Lifecycle (SDLC)

Preferred Education and Experience: 

• BA/BS in a scientific discipline
• 10+ years’ experience in pharmaceutical QA
• Strong knowledge of GCP and GMP requirements, including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and specific regulatory authority requirements (FDA, EMA, PMDA, etc.)
• Experience working with enterprise systems, integrations, and phase-appropriate QMS implementation
• Experience with managing budgets

The pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 – $226,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

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