Zs Pharma Work Values

Daily Duties at Zs Pharma:

Responsible for an independent API and finished drug product Regulatory Compliance department performing across multiple sites, leading key strategies for cGMP, GLP, GCP, PV and EHS compliance, as well as leading pre-approval inspections in support of clinical trial applications, clinical manufacturing and market approval of the company’s initial product in the US, Canada and Europe. Identified compliance requirements, resolved key quality issues, established and implemented Quality Systems, providing effective communication, experience and influence in a team environment to internal partners, colleagues and contractors. Prepared for, trained team and managed regulatory inspections and corporate audits. Built a strong quality and compliance presence to a growing company, through effective mentoring, training, a positive approach and collaborative manner. Hired during late stage 3 and assisted with NDA filing, building a strong and successful commercial organization. Responsible for overseeing the Quality organization as it transitioned from a clinical scale to a commercial manufacturing environment. Reported to the COO, providing technical/regulatory expertise and professional leadership for the continuing development and implementation of successful Quality systems. Identify and assess areas of compliance vulnerability and risk then lead and provide direction for establishment of Quality Management Systems including product development, technical transfers, facility expansion, commercialization, investigation handling, CAPA, change control, documentation systems, data integrity, product complaints, process control, validation, stability, the Quality Review Committee, PDMA, product launch, child-resistant testing, EHS and management escalation. Write and revise standards and procedures assuring the highest level of compliance and quality. As part of the leadership team during PAI readiness, acquisition and expansion, provide guidance on matters related to compliance with laws and regulations.

What they like about Zs Pharma:

Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

Tags

Quality Assurance, Quality Management, Management, Manufacturing, Support, Documentation, Filing, Pharmaceutical, Compliance, Leader, Vice President, Head, Quality, Regulatory, Inspection Readiness, Submissions, GMP, GCP, PV, Strategy, Regulatory Agency, API, OTC, Pharmaceuticals, Sterile, Warning Letter, Consent Decree, Clinical, Oversight, Validation, Safety

Skills

Crisis Management, Mentoring, Regulatory Agency Communication, Internal Consulting, Auditing, Problem Solving and Decision Making, Gap Analysis and Remediation, Quality Management Systems , Investigation Handling, Regulatory Submissions, Networking, Inspection Management, Validation, Lab Management, Quality Assurance, Ethics, Change Management, Collaborative, Positive, Team Leadership, Hands-on Technical Professional

These are some of the questions we asked our climbers about their experiences with Zs Pharma: