Director, Quality & Compliance

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

• Manage the daily operations of the Quality Assurance department including QA employees.  This involves performing and supervising all activities of the department including, but not limited to, batch records, line clearances, audits, vendor qualification, raw materials quarantine and release, deviations, CAPAs, complaints, clinical labeling, document control, training, and review of laboratory data and environmental monitoring reports.
• Involvement in out of specification investigations providing quality as well as input to the design experiments to identify possible sources of problems.  Will ensure that investigation documentation is completed in a timely manner and corrective actions are implemented. 
• Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections. He/she is responsible for authoring responses to audit observations, implementation of corrective actions and confirmation of completion of corrective actions.
• Drafting quarterly GMP quality metrics, reporting results to senior management, coordinating improvement on past performance, ensuring completion of action items.
• Intimately involved with review and approval of validation protocols for the GMP facility, lab and manufacturing equipment, and GMP utilities.  Required to have technical knowledge of each system and their validation requirements.  Responsible for review/approval of validation reports. 
• Ensuring that the employee training program is administered and managed per requirements.  Manage the monthly group SOP refresher training sessions, new employee training, annual GMP training whether performed in-house or use of external consultants.
• Active participation in Senior Staff Meetings contributing to the continual improvement of the organization.
• Recommending and enabling improvements in quality systems, processes and SOPs to elevate the level of compliance of the business.
• Management and career mentoring of QA employees and whenever needed employees of other departments. 
• Responsible for communication with all regulatory agencies
• Responsible for establishing and maintaining licenses (CGMP, State, FDA, DEA and etc.)
• Perform other duties as required.

·        This job description is subject to change at any time.

Requirements

• BS or MS degree in Biology, Chemistry, Pharmacy, or a related scientific discipline
• Minimum 12 years of Quality Assurance experience in pharmaceutical or related industry and 5 years of which includes management experience; or equivalent combination of education, training and experience.
• Extensive working knowledge of GMP regulations and experience with regulatory compliance inspections.
• Strong knowledge and experience with 21CFR210, and 21CFR211
• Ability to effectively lead teams and manage staff; Strong project management and organizational skills;
• Excellent interpersonal skills (including listening, writing, negotiation, facilitation, attention to detail and presentation skills)
• This position is responsible for compliance with all safety regulations, and Mechanical/Electrical/Fire Hazards encountered in Manufacturing/Laboratory Areas
• Includes daily contact with all personnel and regular contact with management
• Frequent contact with Clients
• Primary contact with FDA, DEA and other regulatory agencies
• The following are examples of exceptional skills which may be used as a guide for achievement and consideration for advancement.
• Detailed attention in job performance
• Improvement on the quality system
• Good attitude, work ethic and natural leadership
• Achievement of an advanced degree or certification
• Excellent written and verbal communication

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.