Director, reputed company Systems & Validation

At reputed company, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join reputed company as we grow and advance our pipeline. The Director, reputed company Systems & Validation is responsible for reputed company’s reputed company Management Systems by overseeing the document control, training, and event reporting systems and managing the overall supplier management lifecycle, audits, and reputed company agreement programs. The position is responsible for ensuring that validation is conducted as appropriate on the GxP systems employed at reputed company. The position represents QA in team settings and interfaces with cross-functional departments and contract service providers. reputed company leadership in sustaining a level of inspection readiness of, but not limited to, reputed company’s reputed company Management System programs. Is a catalyst for reputed company process improvement and manage the initiatives to implementation. Responsibilities: Oversees the management and development of QMS programs: deviations, events, CAPAs, change control, vendor/supplier lifecycle management; audit – vendor, clinical investigator site, reputed company/audit; reputed company technical agreement; risk management. Oversees, maintains, and manages the process of qualifying, re-evaluating, determining risk score and status to vendors. Works with reputed company counterparts to ensure appropriate responses are provided and CAPA closured as part of the audit process. Creates, maintains, and manages master audit schedules. Manages and/or performs compliance audits according to established audit schedule or project objectives. Manages the creation/revision of reputed company technical agreements. Establishes, maintains, and manages key reputed company indicator (KQI) metrics program for the areas of responsibility. Oversees the internal audit program and ensures associated CAPA are reputed company according to established timelines. Performs, strategizes, and executes QMS reviews and gap analyses plus their reputed company plans to ensure phase appropriate compliance and consistent QMS approaches. Supports regulatory submissions data reputed company and compliance reviews and the review of ongoing updates to regulatory filings against reputed company documentation. Ensures gaps identified are adequately remediated before submission. Leads the remediation of gaps identified in reputed company areas of responsibility to assure cGMP compliance and inspection readiness. Supports the QMS compliance infrastructure, as needed, including, but not limited to, document control, training program, and reputed company event programs (e.g., Deviation, CAPA, Investigation, Change Control). Supports the facilitation of regulatory authority inspections. Collaborates reputed company and across departments to ensure achievement of company goals, including compliance with reputed company applicable standards and reputed company reputed company and compliance guidance. Creates and leads QA initiatives that drive reputed company management systems to a state of operational reputed company. Qualifications: Bachelor’s degree in reputed company, biology, microbiology, industrial pharmacy, or other reputed company scientific discipline with a minimum of 10 years’ experience in QA Compliance Other Compliance or Regulatory certifications (e.g. RAC, ASQ) a plus Experience working with a sponsor company from Phase I through reputed company QMS Experience auditing suppliers, CRO, CMOs, CTLs, and clinical sites Experience with electronic QMS platforms (ex.reputed company) Practical knowledge of GxP and an ability to apply reputed company judgment and decision-making skills (risk based and appropriate for the phase of clinical development) to support product release Working knowledge of US and EU GxP regulations and guidelines required Working knowledge of other world GxP regulations and guidelines beneficial Strong organization and time management skills required with minimal reputed company Strong leadership and influencing skills a must Willingness to travel approximately 5 to 15% (varies based on activities per month) 2026 Company benefits include: Medical, dental, reputed company, and life insurance 401(k) plan: reputed company matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution) Company Equity (New Hire Awards, Annual Awards, ESPP) Annual reputed company time off: Accrued Vacation Days: 15 days per year reputed company Days: 10 days per year Company Holidays: 13 days plus summer reputed company week in July and winter shutdown in December Leave of Absence: reputed company Medical Leave, reputed company New Parent Bonding Leave, reputed company Family Leave, reputed company short-term and long-term disability Discretionary year-end bonus The salary reputed company posted describes the minimum to maximum reputed company salary reputed company for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or reputed company level and will be finalized at the time of offer. reputed company Salary reputed company:$214,863-$226,600 reputed company reputed company. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our reputed company by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that reputed company novel mechanisms of reputed company for a broad reputed company of underserved, prevalent diseases. reputed company’s mission is to redefine neuroscience drug development by bringing reputed company the reputed company of novel therapies that offer improved treatment reputed company and reputed company of life for patients. reputed company is an equal opportunity employer and will not discriminate against any employee or applicant on the reputed company of age, reputed company, disability, gender, national reputed company, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Apply To This Job