Senior Manager, Quality Assurance, GCP Cytochroma, Inc.

Job Purpose:

Through partnership with Clinical Services and other functions, GCP QA operations is responsible for ensuring high quality clinical trails are performed in compliance with worldwide regulatory expectation. Under the direction of the Director of Quality Assurance, develops, implements and coordinates the clinical quality assurance functions of Cytochroma Inc. This includes managing activities, technical services and document control functions related to Cytochromas clinical programs.

Duties and Responsibilities:

Development of QA strategy for auditing of GCP activities globally and proactive strategic planning for QA support of clinical development activities.
Defines and manages QAs role in clinical projects to support drug development globally.
Manages quality assurance, technical services and document control functions for Cytochroma clinical operations.
Responsible for implementing and maintaining quality assurance and quality control SOPs to assure compliance to external regulatory requirements in clinical operations.
Assures that investigational drug product supply and handling conform to intended study protocol design; including manufacturing, packaging, shipment, storage, labeling and coding.
Reviews quality assurance practices to improve the quality of clinical operations.
Works with the Clinical Research staff to assure investigator qualification and agreements are in compliance, protocol content is appropriate and provides the required information for approval and ensures compliance to the protocol throughout the study, promptly address any internal or site deviations and the CRO/site interactions to support these activities.
Ensures that contractors, vendors and consultants used in regulated activities are appropriately trained and qualified.
Manages the review, investigation and follow-up on non-medical complaints.
Responsible for rapid issue escalation and resolution with appropriate risk management to ensure project continuity and compliance are maintained.
Proactively promotes cross discipline and functional teamwork, and quality culture throughout company.
Provides quality assurance expertise to company personnel and senior management/executives.
Performs other duties as assigned by the Director, Quality Assurance.

Qualifications:

Superior management, analytical, strategic, decision making, interpersonal and mentoring skills.
Proven ability to generate new ideas, processes and strategies to improve department
Proven track record of building effective internal and external relationships.
Ability to work effectively with cross-disciplinary teams and with vendors.
Extensive knowledge of quality assurance requirements regarding the development, testing, release, and distribution of marketed and/or investigational drug products in the US, Canada and EU.
Experience in research quality assurance, good clinical practices (GCPs), and management of clinical trials required.
Experienced with auditing vendors and study sites required.
A high level of regulatory knowledge and laws applicable to the clinical research industry.
Minimum of a Bachelors Degree in a scientific discipline
Minimum 5 years in a management position with drug development and/or commercial stage pharmaceuticals.

Location:	Bannockburn, IL United States