Sr Manager - Associate Director, Quality
The position is responsible for representing quality in clinical project team meetings ensuring studies are performed in compliance with Theravance Biopharma procedures and all applicable GCP regulatory requirements. The incumbent will provide project team quality/compliance and will ensure phase appropriate quality systems, quality plans and quality indicators are established that are in compliance with applicable cGCP regulatory requirements, guidelines and industry best practices. The incumbent will advise management of any significant quality/compliance risks to clinical development programs and from a portfolio perspective in a timely, clear manner, mentoring and development of staff, provide management updates/reports on a regular frequency and escalate critical issues in a timely manner.
Duties and Responsibilities
The incumbent is responsible for executing on policies, procedures and systems to support development activities in compliance to Theravance quality standards and applicable GCP and GLP requirements. These responsibilities include:
- Represent Clinical Quality in clinical phase 1-4 sub-team meetings.
- Identify, revise or assist with the development of quality systems for Clinical Quality and Clinical Operations to enhance execution, compliance and quality of studies.
- Partner with Clinical Operations to identify process improvements and best practices and new technologies for building quality requirements into the scientific and operational design and execution of clinical trials.
- Representing Clinical Quality at operational and cross functional meetings.
- Develop and implement written quality management plans to support all Clinical development activities for corporate projects.
- Review scientific protocols, technical reports and other documentation in support of drug development and regulatory submissions.
- Work with GXP Compliance to ensure audits of CROs, specialty service providers (i.e. EDC, e-diaries, IXRS, etc.), database audits, clinical sites and regulatory documents are performed in accordance to project team timelines. Support GXP Compliance with regulatory inspection readiness activities when required.
- Maintain current knowledge of regulatory requirements and thorough understanding of inspection trends and execute on programs that advance quality requirements and systems designed to meet standards in a cost effective manner.
- Define, collect and report on quality indicators, metrics and using trending tools to monitor effectiveness of quality systems and continual improvement opportunities.
- Provide GCP training sessions for internal and contract personnel in support of clinical development objectives.
- Assist with the oversight of consultants as needed.
- Other assignments as directed by Quality/Regulatory Management.
- B.S. or advanced degree in chemistry, biology or related science with 10-12 years experience in pharmaceutical / biopharmaceutical industry.
- 10+ years in Quality.
- Working knowledge and interpretation/implementation of GCP regulations, familiarity with regulatory guidelines and experience dealing with regulatory authority inspections is a plus.
- Ability to deal with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple.
- Proven ability to lead quality initiatives effectively and advocate a strong quality culture.
- Strong organizational skills, able to prioritize work, effectively manage multiple projects while maintaining attention to detail and meeting timelines.
- Ability to work effectively with various technical and operational groups, with strong oral, written and interpersonal skills.
- Experience with developing, implementing and administrating effective quality systems, auditing clinical operations, reviewing of regulatory submissions.
- Travel may be required (avg. 25% or less).
- Strong working knowledge and interpretation/implementation of GCP and GLP regulations, familiarity with worldwide regulatory guidelines and experience dealing with regulatory authority inspections is required.
Senior Manager/Manager, GCP Quality