This job is archived
(Archived) AD, HPS Strategic Network Quality & Compliance (Remote)
Job Description
Compensation Data
This position offers a base salary typically between $120,000.00 and $205,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Description
Duties & Responsibilities
- Maintains up to date, current understanding of requirements for compliance with US and other key International regulatory authorities (EMA, China, Russia, TGA etc.) applicable to cGMP, Quality systems, Product safety and security etc.
- Develops, maintains, and sustains a Virtual Knowledge management platform as an on-going resource to all One HP Network sites to support regulatory audit preparation and logistics both pre and post inspection.
- Implements processes to share industry trends, key learnings, and best practices regarding regulatory authorities.
- Identifies necessary process improvements for the Network and initiates inter-company CAPAs as applicable.
- Composes and disseminates standardized internal communications on important compliance developments, company policies and procedures.
- Develops, initiates and coordinates baseline assessments (as needed) and training on inspection preparation, gap assessment and risk management, authority interactions, and other related topics critical to maintaining and sustaining site inspection readiness.
- Project management: supports sites as assigned on key projects that enable and sustain inspection readiness.
Requirements
- Bachelor’s Degree with focus in Chemistry, Biology, Pharmaceutical Science, or related field preferred.
- A minimum ten (10) years’ relevant work experience in a regulated pharmaceutical environment. Experience can be a combination of Quality Assurance, Regulatory Compliance, Quality Control and Project Management.
- Preferred experience with Biopharma and regulators overseeing Biologics compliance (i.e., CBER).
- Strong communication skills (Verbal and Written) in English with Spanish(preferred).
- Demonstrated negotiation and influencing skills; risk and scientific decision making.
- Demonstrated project management capabilities. Establish project teams and effectively execute the DMAIC process to improve processes and procedures.
- Demonstrated proficiency with electronic media, leverages technology to strengthen connectivity and access to information. Ability to develop and effectively execute electronic solutions to enhance training and knowledge management.
- Strong inter-cultural skills.
- Ability to establish and execute effective training.
- Ability to travel domestically and internationally (approximately 30%).