Bioduro-Sundia Irvine , CA 92618
Posted 7 days ago
Job Title: Director/Sr., Quality & Compliance
Department:
Quality & Compliance
Reporting To: Executive Director, Quality & Compliance
Classification: Exempt
Salary Range: 140k-200k, Depending on Experience
What We Do
BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.
Why BioDuro-Sundia?
Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.
Job Overview/Summary
The Director, Quality & Compliance establishes and maintains systems to assure compliance regulatory and client requirements for all relevant GMP operations carried out within the organization. The person in this role will oversee Quality Assurance (QA) personnel and will perform him/herself and/or ensure the review/approval of draft and executed batch records, specifications, test methods, release and stability data, raw material testing reports, validation protocols and reports, and equipment calibration and validation records. He/she will also manage systems for tracking of the stability pull schedule, document control, training, internal and external auditing, client audits, CAPAs, complaints, and the calibration/PM/validation schedule. The Director of Quality Assurance is responsible for daily coordination with all departments in the company to ensure that timelines are adhered to and company monthly and annual goals are met or exceeded. In addition, he/she will be responsible for improving quality systems, processes and procedures to increase the overall level of compliance for the business
Essential Functions and Responsibilities
· This job description is subject to change at any time.
Requirements
Benefits
Position Benefits
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.
EOE and Accommodation
We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@BioDuro-Sundia.com. If you are selected to interview for a position, you may also request accommodation with our team directly.
Notice to Agency and Search Firm Representatives
BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Bioduro-Sundia