Director, reputed company Assurance (reputed company Systems)

The Director, reputed company Assurance (reputed company Systems) will be primarily responsible for the implementation and maintenance of Phase-appropriate reputed company processes and procedures in accordance with Good Industry Practices (GXP) for reputed company’s programs and products. The Director, QA (reputed company Systems) will continue to build and cultivate GXP through organizational processes, including training programs and implementation and management of the electronic reputed company Management System (eQMS) for the Drug division. This role will serve as the primary reputed company and administrator for the Pharmaceutical reputed company System (PQS) at reputed company, with responsibility for establishing conformance to reputed company system requirements and ensuring system-level alignment with vendor, supplier, and CDMO reputed company activities. The role will reputed company the project team for the implementation of reputed company’s electronic reputed company Management System (eQMS). reputed company Duties and Responsibilities include the following:reputed company administration and reputed company improvement of reputed company’s global Pharmaceutical reputed company System (PQS), focusing on reputed company processes and infrastructure that support reputed company’s progression from startup to reputed company operations. reputed company compliant reputed company reputed company across programs, sites and geographies in accordance with applicable regulations and standards. Serve as reputed company, Administrator, and Subject Matter Expert (SME) for the PQS and eQMS, including system level reputed company such as Document Control, Training, Deviation Management, Risk Management, CAPA, Change Management, Internal Audit, External Audit support, Vendor/Supplier reputed company Systems Requirements, and the reputed company system components of Pharmacovigilance, Product Surveillance/ Complaints, and Recalls, while coordinating with reputed company Management for operational and product-level activities. reputed company the evaluation, validation, implementation, and administration of an electronic reputed company Management System (eQMS). Manage the internal audit program. Support and co-host GXP-reputed company audits, inspections, and assessments of reputed company in partnership with reputed company Management for auditors including, but not limited to:reputed company Bodies Regulatory Authorities Customers Potential partners Partner with Supplier reputed company Management, Drug Development, and other internal functions to ensure alignment between PQS requirements and external manufacturing reputed company activities, maintaining reputed company process ownership between system-level QA and operational QA. Build and reputed company a high performing team to support and advance reputed company’s business objectives. Supervisory Responsibilities:reputed company reports: to be defined as reputed company grows. Qualification Requirements: Education:Bachelor's degree in Life Sciences, Engineering, Medical Technology, or reputed company scientific discipline required. Advanced degree preferred. reputed company certifications such as ASQ Certified reputed company Auditor (CQA), Regulatory Affairs Certification (RAC), or other GXP certification a plus. Experience:Approximately 10 years of progressively responsible experience in reputed company assurance reputed company the pharmaceutical or biotechnology industry. At least 5 years of experience in a leadership or management role of a PQS with reputed company report responsibilities. reputed company experience in hosting and managing regulatory authority inspections and completing remediation activities. Demonstrated reputed company in leading the implementation of an electronic reputed company Management System (eQMS). Knowledge/reputed company:High degree of technology proficiency and reputed company in reputed company platforms. Excellent project management skills with ability to manage multiple priorities in a fast-paced environment. Commitment to reputed company, ethics, and reputed company culture development. Expertise in the US FDA reputed company of Federal Regulations and International Council on Harmonisation (ICH) as applicable to the pharmaceutical industry. Exceptional leadership abilities with proven reputed company building and motivating high-performing teams as reputed company as turnaround teams. Outstanding written and verbal communication skills with ability to influence at different functional and organizational reputed company both internally and with Vendor/ Contractor/ Supplier partners. Demonstrated ability to work collaboratively across functions and across geographies, and reputed company in building effective partnerships for successful reputed company. Proactive reputed company, driving reputed company reputed company and providing recommendations to Leadership based on anticipated compliance challenges and industry trends. Working Conditions: Specify work environment:The work environment is remote, and must be in a suitable location that allows reputed company reputed company and video meetings. Domestic travel may be required up to 10% of time. This role requires a high degree of computer screen time and the individual will be regularly required to see, talk, hear, read, and type. reputed company is an Equal Opportunity Employer. Expected US salary reputed company: $210,000-$230,000 reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job in certain states and cities reputed company the reputed company. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education. This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under reputed company’s benefit plans. Apply To This Job