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Job Title: Quality Systems Manager

Department: Quality & Compliance

Reporting To: Director, Quality and Compliance

Classification: Exempt

Salary Range: 100k-140k

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 Quality Systems Manager, under limited management, ensures compliance with cGMP and company policies, procedures and specifications. Responsible for supervising Quality Assurance Associates activities of Quality Operations include batch record stage review, raw material and bulk product releases, production quality inspection/ sampling/testing, shop floor monitoring, etc. with cGMP and company procedures, state, federal, DEA, local law.

Essential Functions and Responsibilities

• Oversight of the Batch Disposition and Documentation team. Client communication as needed.
• Collaboration and approval of MBRs, Raw Material, API and Label Specifications.
• Issuance of Material Code Numbers.
• Issue batch records, logbooks and QC notebooks as needed.
• Communicate batch record errors with Manufacturing and provide guidance to the team to ensure projects are meeting the manufacturing schedule and client deadlines.
• Review executed batch records, disposition raw material and final product.
• Issuance of labels for clinical manufacturing utilizing a Brady printer.
• Keep open dialogue with team through VCB or similar.
• Collaborate with various departments to meet quality requirements and fulfill business needs.
• Provides manager with quality indicator data.
• Coordinates interdepartmental activities with Supply Chain, QC and Operations to meet business needs.
• Responsible for quarantining/rejecting product due to investigations disposition, field alerts, recalls, etc.
• Reviewer of executed packaging and manufacturing batch records.
• Author and review SOPs relevant to the job duties.
• Initiate deviation reports and supports investigative process.
• Monitor manufacturing and packaging processes to assure cGMP compliance and adherence to company SOPs
• Assist internal quality initiatives and internal audits as required; assist as needed with FDA inspections.
• Provides guidance, training, cross-training, coaching and work assignments for QA Associates.
• Selects, develops, evaluates personnel to ensure efficient operation of QA function.
• This job description is subject to change at any time.

Requirements

• Bachelors degree in Chemistry, Life Science, or related field.
• 7+ years of related experience in in a cGMP/pharmaceutical environments or equivalent.
• 2+ years supervisory experience.
• Understanding of cGMP principles, solid dosage manufacturing and packaging, DEA regulations
• Solid understanding of batch record review and disposition
• Solid investigation write up skills including root cause analysis techniques.
• Intermediate computer skills.
• Leadership and Training skills are a must.
• Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, and moderate noise levels. Work is performed in a cGMP environment.

Experienced in training techniques.

Preferred Qualifications

• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
• Customer Service - Manages difficult or emotional customer situations; responds promptly to customer needs; solicits customer feedback to improve service; responds to requests for service and assistance; meets commitments.
• Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
• Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Able to effectively handle conflict/resolution situations between different departments and inter-department.
• Able to analyze and troubleshoot problems.

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 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.