Manager/Senior Manager, QA Analytical

Job Title: Senior Manager, QA Analytical

Department: Quality & Compliance

Reporting To: Director, Quality & Compliance

Classification: Exempt

Pay Range: 115k-128k, DOE

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 10 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 Manager/Sr. Manager, QA, provides oversight and support for QC/ Analytical Development, Materials Management to ensure compliance to regulatory and client requirements for all GMP operations.

Essential Functions and Responsibilities

• Investigation Support - Participate in laboratory investigations and ensure corrective and preventive actions are implemented. Provide oversight and hands-on support change management and customer complaints.
• Materials Management Support - Provide oversight and hands-on support for Materials management in assignment of material codes, review and approval of raw material and packaging component specifications, and materials disposition.
• Annual Product Review - Oversee and be back up for generating score cards and writing annual product reviews.
• Analytical Support - Provide hands-on support for data review/approval of analytical testing data summaries (including, but not limited to, in-process, release, stability, method validation, and cleaning validation/verification testing) and ensuring tasks are tracked, timelines are met, and investigations into testing failures and deviations are initiated and closed out according to BioDuro's procedures.
• Audits and Regulatory Inspections - Lead, participate and assist with internal and external audits and regulatory inspections. Work with the QA group to ensure BioDuro inspection-readiness, including compliance with relevant parts of the CFR, GMPs, company policies and procedures and other established standards

• Other duties as deemed appropriate by the Supervisor or Head of Quality.

Requirements

• Bachelor's degree in science-related field is preferred.
• Minimum 7 years of experience in GMP manufacturing experience, minimum of three years of experience in Quality Assurance
• Strong project management, critical thinking, and organizational skills
• Excellent interpersonal skills (including listening, writing, negotiation, facilitation, attention to detail and presentation skills)
• Hands-on experience performing production line clearance, reviewing, and approving draft and executed production batch records, review and approval of deviations and implementation of corrective and preventive actions.
• Working knowledge of applicable CFR, ICH, and GXP regulations.
• Well-lit, heated and/or air-conditioned indoor office and laboratory setting with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature. May require long periods of standing/sitting. Dirt/Dust/Heat/Noise/Fumes/Odors/Vibrations encountered in Manufacturing Area.

Preferred Qualifications

• Detailed attention in job performance
• Leading/Facilitating 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

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 [email protected]. If you are selected to interview for a position, you may also request an 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.