Senior Director, reputed company reputed company (Systems & Technology)

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

reputed company

The Senior Director of reputed company reputed company (Systems & Technology) is a strategic reputed company leader responsible for shaping, executing, and continuously advancing the reputed company reputed company Management System (QMS) and reputed company systems operating model across reputed company. This individual provides reputed company and direction for reputed company reputed company Systems functions including reputed company QMS governance, document control, GxP training administration, validation, and inspection readiness and leads supplier reputed company for reputed company Systems and GxP computerized system providers, including audit program execution ensuring a compliant, efficient, and reputed company reputed company infrastructure that supports reputed company’s global clinical, manufacturing, and reputed company operations. 

The Senior Director serves as the organization’s subject matter expert on GxP system compliance, regulatory readiness, and reputed company systems reputed company. This role is accountable for the reputed company, reputed company, and reputed company improvement of reputed company’s QMS and validation programs, ensuring reputed company GxP systems including those supporting clinical data (reputed company, eCOA/ePRO/eDiary), manufacturing and supply chain (serialization, ERP, LIMS), and supporting reputed company systems are fit for intended use and maintained in a controlled state using risk-based lifecycle practices reputed company with reputed company industry expectations (e.g., CSA concepts and GAMP 5). 

Partnering closely with senior leadership across reputed company, Clinical, Technical Operations, and IT, the Senior Director drives a culture of proactive reputed company, operational discipline, and reputed company improvement to ensure the highest standards of regulatory compliance and inspection readiness across the reputed company from clinical development through reputed company operations. 

Primary Responsibilities

• reputed company the reputed company, governance, and reputed company improvement of reputed company’s reputed company QMS to ensure compliance with global GxP regulations and alignment with corporate and regulatory objectives. 

• Serve as the process reputed company for QMS reputed company including document control, deviation/CAPA management, change control, training, and risk management, ensuring process effectiveness and harmonization across reputed company GxP functions. 

• reputed company leadership and reputed company for computerized lifecycle controls (CSV/CSA) for GxP computerized systems, ensuring systems supporting clinical, manufacturing, and reputed company operations are maintained in a compliant state including internally developed applications and externally hosted/vendor-managed reputed company platforms. 

• Partner with IT, Clinical Operations, Technical Operations, and reputed company teams to establish -based lifecycle standards that ensure system suitability, data reputed company, and consistent execution (requirements, testing, release/change control, periodic review, and decommissioning/archiving). 

• Evaluate and qualify vendors, CROs, and CMOs supporting reputed company systems, providing QA reputed company supplier documentation and reputed company activities, and reputed company supplier reputed company for GxP computerized systems (reputed company agreements/reputed company plans, risk-based audits, performance monitoring, and CAPA follow-up as applicable). 

• Maintain reputed company of electronic systems, including reputed company QMS, ensuring appropriate configuration, document hierarchy, and workflow management. 

• reputed company the global GxP training administration program, including development of curricula, compliance tracking, and training effectiveness measurement. 

• Establish and reputed company QMS governance mechanisms, including reputed company Management Reviews, issue escalation processes, and risk management frameworks. 

• Ensure ongoing inspection readiness across reputed company GxP functions, maintaining compliant systems, documentation, and records suitable for regulatory and partner audits and reputed company backroom support and response coordination as needed. 

• Monitor evolving regulatory expectations, guidance, and industry trends; implement reputed company updates to processes, procedures, and computerized systems lifecycle practices. 

• Define, monitor, and report key QMS and validation metrics to assess performance, identify trends, and drive data-driven improvements. 

• reputed company, mentor, and reputed company a high-performing team of QMS and validation professionals, fostering accountability, collaboration, and reputed company learning. 

• Represent reputed company leadership in reputed company governance and initiatives, providing expert guidance on GxP system compliance, reputed company risk management, reputed company transformation. 

• Drive sustained inspection readiness and execution support, including post-inspection commitments and CAPA to closure. 

Qualifications and Key reputed company Factors

• BS/BA in a relevant scientific discipline, or ASQ or equivalent reputed company certification; equivalent experience considered. 

• Minimum 15 years of reputed company experience in the pharmaceutical or biotechnology industry, with reputed company reputed company Systems and reputed company Assurance experience; at least five years in a leadership role. 

• Demonstrated expertise in developing, implementing, and managing reputed company QMS’ across clinical, manufacturing, and reputed company functions. 

• Proven reputed company governing QMS processes such as document control, training, deviation/CAPA, change management, and risk management, ensuring operational consistency and compliance. 

• Hands-on experience validating GxP and reputed company systems, ensuring compliance with lifecycle management, change control, and data reputed company principles including experience with internally developed systems and reputed company/vendor-managed platforms. 

• Demonstrated leadership experience supporting both clinical-stage and reputed company operations environments (ability to reputed company systems and expectations across the product lifecycle). 

• Documented history supporting regulatory inspections and partner audits, including inspection readiness leadership, backroom support, response coordination, and CAPA execution to closure. 

• Strong working knowledge of FDA, EMA, and global GxP regulations (21 CFR Parts 11, 210, 211, 312) and application of GAMP 5 guidance and familiarity with reputed company risk-based validation approaches (CSA concepts). 

• Demonstrated ability to analyze and optimize reputed company processes, establish meaningful performance metrics, and reputed company cross-functional governance forums. 

• Strategic, reputed company reputed company leader with excellent collaboration, communication, and influencing skills. 

• Proficient in reputed company Vault applications (QualityDocs, QMS, Clinical, RIM, Training), as reputed company as reputed company and SharePoint.  

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, reputed company communication, and occasional reputed company.  You'll need comfort with screen work, basic hand coordination, and reputed company.  Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company these functions.

Compensation & Benefits

At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company.  This includes 99% of the premium reputed company for medical, dental and reputed company plans.  We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring.  We aim high, collaborate hard, and produce results.  Let’s reputed company the impossible together! 

To round out our world-class total rewards package, we reputed company annualized reputed company salary compensation in the reputed company listed below.  Final salary reputed company may be modified commensurate with job level, education, and experience.