At viridian, we aim to advance new treatments for patients underserved by today’s therapiesOur team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseasesWe strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for successWe value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
We seek an experienced quality compliance professional to lead evaluation and prioritization of new program ideas for treating serious and poorly managed diseases, with the goal of maintaining a sustainable product-focused portfolio.
Reporting to the director of quality assurance, the quality assurance compliance manager is responsible for the management of quality assurance systems and programs that align with corporate goals and comply with applicable regulationsThe incumbent will work collaboratively with internal stakeholders to ensure compliance with policies and procedures and serve as a point of contact with vendors and external auditors.
Document control eqms responsibilities
Point person for electronic document management system (edms) Write, revise, and periodically review sops. Collect and maintain documents necessary for gxp compliance (i.e., training records, sops, master batch records, technical study reports, stability studies) Works directly with edms/eqms vendor to implement modules, execute upgrades and validations for eqms Manage implemented eqms modules (i.e., documents, training, etc.) Works with members of the quality team to ensure required documentation is appropriately entered and maintained in the electronic document system.
Quality systems compliance
Establishes and/or maintains internal quality systems (policies/procedures/systems) including internal auditing, training, change control, deviation, capa and risk assessment. Maintains vendor/supplier evaluation programs; conducts supplier evaluations and approval of supplier evaluations. Conducts external vendor audits (gcp/glp audits excluded) and internal department audits. Oversight and approval of internal/external audit schedules a Ensures maintenance and adherence to the quality manual. Works with other department heads/cross-functional team to establish and maintain compliance with regulatory guidance and internal standards. Approximately 10-15% travel
B.s./b.aIn chemistry, biology, or a related life science; 5-10 years of experience within gmp quality functions of pharmaceutical/biotech industry Working knowledge of qms implementation and management Clear understanding of fda and international regulatory requirements Experience in the area of therapeutic antibodies highly desired, rare disease experience a plus. Knowledge of mastercontrol and/or veeva strongly preferred. Internal and external auditing experience Adept at prioritizing and completing tasks in a high-pressure environment. Ability to persuasively and effectively interact with partners, collaborators, and cro’s. Demonstrated ability to anticipate and address issues. Exceptional oral and written communication skills including excellent technical writing abilities. Strong execution of day-to-day activities
This role will be based in viridian’s boulder co office, but remote work may be considered.
Compensation: the salary range for this position is $120,000-$150,000 and commensurate with experienceViridian offers a comprehensive benefits package including:
Medical, dental, and vision coverage with 100% of premiums paid by viridian for employees and their eligible dependents. Short- and long-term disability coverage Group term life insurance Medical and dependent care fsa 401(k) company match Employee stock purchase plan
Viridian therapeutics, incProvides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws.
Quality Compliance Manager
Applying through jobeka.lk CV will be a benefit for you to prioritize your CV