Associate Director, Document Control at Corcept Therapeutics

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Proven track record of advancing document control by remediating critical gaps and implementing sustainable, risk-based controls that achieve GxP requirements
Pharmaceutical or biotechnology experience involving single product to multi-product transformation, including design of scalable business processes, modification of computer systems, and updating metadata
Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
Ability to support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines
Ability to build effective partnerships across GxP departments including QA, Regulatory, IT
Hybrid role typically requiring on-site presence at least 3 days per week

Responsibilities

Lead and mentor a committed team of Document Control professionals, aligning through shared purpose, empowerment, and transparency; foster a culture of ownership, agility, quality excellence, and professional growth
Strengthen the Document Control Program and supporting software by remediating compliance risks, and architecting processes, metadata, and complex computer system configurations including security
Evaluate and implement solutions to support a scalable, multi-product environment in compressed timelines resulting in a robust, inspection-ready program that achieves GxP standards
Partner closely with Training program lead to integrate document process changes and system configuration changes to proactively address organizational change management of impacted personnel
Assume software Business System Owner responsibilities, ensuring data and metadata maintenance and periodic system review
Drive and manage high-volume SOP authorship, revision, and implementation — often under accelerated timelines
Lead technical sessions as needed that elicit system requirements to scale Veeva QDS (QualityDocs) capabilities and ensure projects line up with Quality Systems project portfolio
Establish and track key performance indicators (KPIs) to monitor and ensure system effectiveness, inspection readiness, and accountability

Skills

Document Control

Quality Management System

GxP Compliance

SOP Management

Risk-Based Controls

Pharmaceutical Manufacturing

Biotechnology

Change Management

Stakeholder Coordination

QMS Software

Corcept Therapeutics

Develops cortisol modulators for medical conditions

About Corcept Therapeutics

Corcept Therapeutics focuses on developing treatments that regulate cortisol levels in the body, which is important for managing various health issues. Their main product, Korlym, is used to treat Cushing's syndrome, a condition caused by too much cortisol. Korlym was approved by the FDA in 2012 and is the first medication specifically for this disorder. Corcept stands out from competitors by having a strong emphasis on research and development, having discovered over 1,000 unique cortisol modulators. The company aims to expand its range of treatments while also providing educational resources to healthcare professionals and patients to improve understanding and care for cortisol-related conditions.

Menlo Park, CaliforniaHeadquarters

1998Year Founded

$39.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Flexible Work Hours

Risks

Teva's antitrust lawsuit could lead to legal expenses and market share loss.

Heavy reliance on Korlym makes Corcept vulnerable to market fluctuations.

Recent investments may pressure Corcept for short-term financial performance, impacting R&D.

Differentiation

Corcept specializes in cortisol modulation, a niche with few direct competitors.

Korlym is the first FDA-approved treatment for Cushing's syndrome, a significant market advantage.

Corcept's extensive R&D has led to the discovery of over 1,000 selective cortisol modulators.

Upsides

Increased interest in cortisol therapies for mental health boosts Corcept's R&D prospects.

Advancements in drug delivery systems could enhance Corcept's product efficacy.

The FDA's fast-track designation supports Corcept's innovative cortisol-related treatments.

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