Senior QA GCP Manager

Job Description

This role is responsible for providing Quality Assurance oversight of our clinical trials. Activities include managing clinical trial programs and assuring they are compliant with both external and internal regulations by conducting audits to assess risk and maintaining a risk profile. This role also helps in the development, implementation and maintenance of QA systems and activities supporting GCP operations.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Uses risk management to manage Clinical QA programs to assess and ensure GCP compliance with policies and procedures Actively identifies process improvements and takes initiative to implement improved processes related to Clinical QA activities Provides the Quality framework in support to the clinical study teams, setting standards on what is acceptable for study operations Champions the implementation of Quality Risk Management (QRM) with the Clinical Study Teams and within Quality Assurance Drives certain aspects in developing an appropriate CQA audit schedule including the contracting of GCP audits to contractors Conducts audits as required (simple or complex) Responsible for developing, tracking, and managing periodic management reports including key Clinical and QA metrics Participates in Health Authority inspections as needed; presents for QA on related Clinical Study Teams; supports external audits as required Independently determines the approach to complex compliance issues and escalates to management with recommendations for resolution and verifies appropriateness of CAPAs Authors, reviews and implements Quality Standards and SOPs as needed Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, etc., on identifying and addressing key issues and risks Stays abreast of changes in regulations or industry standards, evaluates the impact and escalates to the appropriate team Participates in the development and delivery of GCP training Represents GCP QA in internal presentations on quality issues, initiatives, and projects

SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education: BS/BA degree in related discipline and eight plus years of related experience; or, MS/MA degree in related discipline and six plus years of related experience; or, PhD in related discipline and three plus years of related experience, or; Equivalent combination of education and experience.

Experience: Requires a minimum of eight (8) years of GxP experience, focused on Clinical Quality Assurance Auditing experience is highly desirable Experience in the biotech or pharmaceutical industry is preferred.

Knowledge/Skills: A deep understanding of the drug development process, particularly focused on Clinical Trial oversight Thorough knowledge of audit conduct and management experience, particularly in GCP and PV disciplines Working knowledge of process and requirements for global submission of Clinical data, particularly in supporting preparation and submission activities. Experienced in using Quality Systems (Quality events, Deviations, Investigations, CAPAs) to drive process improvements Excellent verbal and written communication skills Ability to influence others as part of a collaborative team and negotiate effective solutions Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways. Interprets, executes, and recommends modifications to companywide policies and/or divisional programs. Detailed-oriented in execution of tasks and processes Demonstrated proficiency in Microsoft Office, Smartsheets, and other office software platforms.

WORKING CONDITIONS:

Environment: primarily working indoors, performing clerical work Travel required approximately 10- 25% of time or as required

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.