Senior QA GCP Manager

Job Description

Responsible to assist in the development, implementation and maintenance of QA systems and activities supporting Clinical Quality Assurance operations. Plans and conducts audits of vendors and associated documentation activities.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: Manages QA programs, policies, and procedures to ensure GCP compliance Assists in the development of internal processes and systems related to GCP QA activities Provides GCP strategic support to clinical study teams and participates in QA planning and implementation to support study operations Provides GCP guidance in the oversight and implementation of Quality Risk Management Participates in the development and approval for the CQA audit schedule including the contracting of GCP audits to contractors and conducting complex audits Responsible for developing, tracking and managing periodic management reports including key Clinical and QA metrics Participates in and support various development teams Manages and/or participates in complex audits and regulatory inspections Independently determines approach to complex compliance issues and report findings to management with recommendations for resolution and verify appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented Supports and trains staff and oversee GCP consultants Implements policies and/or procedures within GCP QA Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provide compliance guidance to all audited parties Maintains knowledge of current regulation requirements and inform Clinical Development stakeholders of potential impact on the organization Provides support during external audits and regulatory authority inspections Participates in the development and delivery of GCP training internally 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 seven years of related experience; or, MS/MA degree in related discipline and five years of related experience; or, PhD in related discipline and zero to two years of related experience; or, Equivalent combination of education and experience.

Experience: CQA, GCP, PV experience Experience in the biotech or pharmaceutical industry is preferred.

Knowledge/Skills: Thorough knowledge of the drug development process Thorough knowledge of audit conduct and management experience, particularly in GCP and PV disciplines is required Working knowledge of supporting preparation and submission activities, specifically in relation to GCP Quality, for global regulatory filings. Excellent verbal and written communication skills Ability to influence others as part of a collaborative team and negotiate effective solutions, strong interpersonal and social skills 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 Working knowledge of successful completion of major programs, projects and/or functions Interprets, executes and recommends modifications to companywide policies and/or divisional programs Detailed oriented and committed to precision in execution of tasks and processes Must be proficient in Word, Exel, PowerPoint and Visio.

WORKING CONDITIONS: Environment: primarily working indoors, performing clerical work Travel required – between 10-25% for scheduled auditing, could be more for urgent issues

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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.