Manager, Clinical Development Quality

Lake Forest, Illinois, USA
Aug 20, 2019
Required Education
Bachelors Degree
Position Type
Full time
This position is responsible for executing quality operational activities for Horizon's pipeline of clinical developmental candidates. Duties include: quality project management, quality management system (QMS) oversight, driving continuous improvement initiatives, quality representation, communication, and management of quality issues with both internal and external partners. Supporting and executing quality operational, strategic and tactical goals for QMS and development product(s) in order to assure the highest quality standards and regulatory compliance.

This team member is primarily responsible for management of elements of the QMS, quality projects, continuous improvement efforts and operational quality system elements of deviations, CAPAs, change controls and product complaints. This team member may also be responsible for tactical product execution activities, such as batch documentation review, batch release, and coordination of QP release through internal or external QPs, as applicable. This team member may also be responsible for ensuring the highest quality standards for the product(s) by the tracking and monitoring of batch, stability and quality control data. This team member serves as the analytical, technical, and quality operational expert for product(s), as needed.

Responsibilities, including but not limited to:
  • Quality Project Management
  • Lead quality for product(s) to internal and external partners
  • Management of QMS elements including investigations, change controls, CAPA, product complaints
  • Establishment of phase-appropriate QA procedures and oversight
  • Review of batch documentation and batch disposition of drug substance, drug product, and finished product batches
  • Identification and communication of risks to product, supply, clinical study, or business, propose solutions, escalate and communicate in an appropriate and timely manner
  • Execution and support of internal and external audits
  • Preparation for and participation in regulatory inspections as a subject matter expert
  • Preparation of materials for business reviews and routine operational meetings
  • Oversight of all product testing and analytical methods
  • Assurance of phase-appropriate method development, qualification, and validation
  • Tracking and monitoring of quality control and batch trending data
  • Assurance of safety, identity, and purity of assigned product(s)
  • Coordination of QP release through internal or external QPs, as applicable
  • Establishment of holistic process control strategy and oversight of process performance qualification
  • Key contributor and/or reviewer of IND, IMPD, NDA, BLA, MAA, NDS, etc. materials
  • Facilitate technical and knowledge transfer to commercial quality team members
  • Drive continuous improvements initiatives within and across product portfolio

Qualifications and Skills Required:
  • BA/BS in Chemistry, Biology, Engineering or equivalent required
  • 5+ years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing
  • Knowledge of ISO 13485 and familiarity with other regulatory requirements applicable to a medical device and combination product development and manufacturing operations
  • Experience with drug development from pre-clinical through commercialization
  • Experience with cGMP manufacturing of clinical trial material
  • Expertise in pharmaceutical product quality
  • Ability to work with high level contact and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment
  • Strong written and verbal communication skills
  • Ability to partner effectively with internal and external partners
  • Proficient in Microsoft Office
  • Professional demeanor
  • Self-starter attitude
  • Strong interpersonal skills