|Title:||Director or Senior Director, GCP Quality Assurance|
The Director or Senior Director of Quality Assurance (Sr Dir QA) is responsible for GCP quality assurance, quality control, and compliance operations. The Director or Sr Dir QA will establish quality plans and policies and report to senior management on a regular basis on compliance activities and findings. He/she will design, implement and maintain QA and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits. The Sr Dir QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. The Sr Dir QA will serve as an in-house advisor on GCP compliance.
- Design and maintain Quality Assurance and GxP compliance for all aspects of VenatoRx programs to support clinical studies and future product registration.
- Provide GCP Quality Assurance oversight of vendors and maintain quality agreements
- Write, review, approve and maintain Standard Operating Procedures
- Responsible for reviewing batch records as well as release and disposition of drug substance and drug product batches.
- Ensure training programs throughout VenatoRx meet GCP and ICH requirements.
- Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable VenatoRx SOPs, GXP regulations and applicable country specific standards.
- Oversee compliance (GCP auditing program) to fulfill regulatory requirements.
- Provide expertise and guidance to VenatoRx departments in interpreting and implementing governmental and agency guidelines to assure compliance.
- Follow applicable regulations, including FDA, ICH, GCP, and VenatoRx policies and procedures.
- Ensure that direct reports and consultants have completed the training necessary for their assigned responsibilities.
- Represent QA at project team meetings
- Provides Quality Assurance input to Company strategic goals in form of schedules, quality plans, and budgets.
Successful candidates will be able to demonstrate:
- Minimum BS, Master’s degree or PhD with focus in Life sciences or other similar technical field
- 10+ years of relevant and current work experience in pharmaceutical industry Quality Assurance required.
- Solid and demonstrable knowledge of international GCP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment.
- Working knowledge of GCP international regulations
- Strong organization and time management skills.
- Attention to detail with an ability to perform critical review of various types of documents.
- Outstanding written and verbal skills
- Ability to independently solve problems and work cross-culturally.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Proficiency with commonly used word processing, database systems, document management, and other software.
You may apply to this position online by selecting the Apply now button. PLEASE ATTACH YOUR RESUME
VenatoRx is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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VenatoRx does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact VenatoRx's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to VenatoRx. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and VenatoRx. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of VenatoRx. VenatoRx shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.