Corcept Therapeutics
Associate Director, Document Control
Corcept Therapeutics, Redwood City, California, United States, 94061
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.
We are seeking an Associate Director to lead Corcept’s Document Control Program, an essential element of our Quality Management System (QMS). This leadership role requires a proven track record of advancing document control by remediating critical gaps, and implementing sustainable, risk-based controls that achieve GxP requirements. This role owns the strategy, execution, and compliance of the program and its supporting software.
This leader champions a culture of SOP engagement, and accountability across departments, ensuring that stakeholders adhere to Corcept’s SOP standards. This involves communicating and coordinating SOP revisions involving everything from simple changes to complex system overhauls under compressed timeliness.
This role requires a strong, focused leader who delivers high-visibility changes, drives implementation with resilience and clarity, and resolves obstacles and dynamic priorities. The leader communicates a clear and compelling vision, and guides teams through change using collaborative "come with me" leadership.
The role requires pharmaceutical or biotechnology experience involving single product to multi-product transformation including the design of scalable business processes, modification of computer systems, and updating metadata.
This is a 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
Preferred Skills, Qualifications and Technical Proficiencies
Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
Support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines
Build effective partnerships across GxP departments including QA, Regulatory, IT, Manufacturing, and Development to build solutions
Technical expertise as business owner of Veeva QDS with demonstrated success in transforming systems, associated business processes, and configuration from a single product to a multi-product and multi-geographical site system
Clear and concise written communication skills to align documentation to Corcept’s Quality Policy/Manual, using established Document Control tools to deliver consistent, quality written work
Inspirational leadership style with a proven ability to guide teams through complexity and ambiguity
Experienced in presenting to executive leadership and acting as a visible leader during audits and inspections
Excellent verbal and written communication skills with the ability to influence a wide range of stakeholders in various departments
Strong working knowledge of pharmaceutical GxP standards and their impact on SOPs, work instructions, and controlled documents
Designed applicable document control processes that integrate with GxP Training program
Extensive experience as Business System Owner of Veeva QDS
Preferred Education and Experience
BA/BS degree in a scientific/technical/engineering field
10+ years of experience in pharmaceutical or life sciences industry
The pay range that the Company reasonably expects to pay for this headquarters-based position is $186,500 - $219,400; 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.
Corcept is an Equal Opportunity Employer
#J-18808-Ljbffr
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.
We are seeking an Associate Director to lead Corcept’s Document Control Program, an essential element of our Quality Management System (QMS). This leadership role requires a proven track record of advancing document control by remediating critical gaps, and implementing sustainable, risk-based controls that achieve GxP requirements. This role owns the strategy, execution, and compliance of the program and its supporting software.
This leader champions a culture of SOP engagement, and accountability across departments, ensuring that stakeholders adhere to Corcept’s SOP standards. This involves communicating and coordinating SOP revisions involving everything from simple changes to complex system overhauls under compressed timeliness.
This role requires a strong, focused leader who delivers high-visibility changes, drives implementation with resilience and clarity, and resolves obstacles and dynamic priorities. The leader communicates a clear and compelling vision, and guides teams through change using collaborative "come with me" leadership.
The role requires pharmaceutical or biotechnology experience involving single product to multi-product transformation including the design of scalable business processes, modification of computer systems, and updating metadata.
This is a 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
Preferred Skills, Qualifications and Technical Proficiencies
Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
Support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines
Build effective partnerships across GxP departments including QA, Regulatory, IT, Manufacturing, and Development to build solutions
Technical expertise as business owner of Veeva QDS with demonstrated success in transforming systems, associated business processes, and configuration from a single product to a multi-product and multi-geographical site system
Clear and concise written communication skills to align documentation to Corcept’s Quality Policy/Manual, using established Document Control tools to deliver consistent, quality written work
Inspirational leadership style with a proven ability to guide teams through complexity and ambiguity
Experienced in presenting to executive leadership and acting as a visible leader during audits and inspections
Excellent verbal and written communication skills with the ability to influence a wide range of stakeholders in various departments
Strong working knowledge of pharmaceutical GxP standards and their impact on SOPs, work instructions, and controlled documents
Designed applicable document control processes that integrate with GxP Training program
Extensive experience as Business System Owner of Veeva QDS
Preferred Education and Experience
BA/BS degree in a scientific/technical/engineering field
10+ years of experience in pharmaceutical or life sciences industry
The pay range that the Company reasonably expects to pay for this headquarters-based position is $186,500 - $219,400; 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.
Corcept is an Equal Opportunity Employer
#J-18808-Ljbffr