Manager, Quality Assurance TEMP (Level Commensurate to experience)

Job Title: Manager, Quality Assurance TEMP (Level Commensurate to experience)

Department: Quality & Compliance

Reporting To: Executive Director, Quality & Compliance

Classification: 3-6 month temporary position. Full-time conversion pending on organization need.

Pay Range: $62.98-$67.31/hr (Pay Commensurate to experience)

What We Do

BioDuro 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 is a leading partner of choice.

Why BioDuro?

Take the next step in your career and join BioDuro 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, QA Temp is responsible for compliance and continuous improvement of the Quality Management System and ensures all requirements of product quality are consistently achieved. Ensures products are compliant with QA policies and procedures, cGMPs, SOPs, and is responsible for disposition of lots. Ensures completeness and accuracy of master batch records and investigations. Oversee development, implementation and management of QA programs and initiatives for GMP activities. Ensure all QA programs are aligned with applicable regulations, regulatory standards, and internal procedures. May serve as back-up for Sr. Mgr or dept-specific Director where assigned and appropriate.

Essential Functions and Responsibilities

·         Work with senior management and other Quality staff to oversee the development and implementation of an FDA compliant-Quality System for GMP activities.

·         Assist in the development and maintenance of quality management systems.

·         Perform trending on Quality System; provides evaluation to Senior Management.

·         Create, revise, review, and approve quality-related documents, including but not limited to procedures, memoranda, protocols, batch records and reports.

·         Assist MQA Supervisors/Specialists in solving compliance errors detected during processes.

·         Participate in or lead cross-functional Investigations assigned by upper management.

·         Must make effective decisions in timely manner and be focused on execution until completion.

·         Independently manage simple to complex discrepancies.

·         Lead, participate in, and provide leadership for projects designated by upper management.

·         Recognize trends, deviations, problems and promptly reports them to management.

·         Multitask and manage competing priorities while meeting production timelines.

·         Represent Quality Assurance at meetings.

·         May lead the creation of meaningful CAPA plans with the responsible parties, including reasonable completion dates.

·         Recognize need for investigation due to deviation from written procedures.

·         Perform assigned tasks and work to achieve company goals and department objectives.

·         Member of Quality Improvement teams to address Quality / process issues.  Lead quality process improvements. 

·         Ensure staff determine and define the root cause for laboratory investigations.

·         Oversee review and approval of analytical method validation program and product development data to support drug applications.

·         Review SOPs to ensure compliance with applicable regulatory and corporate standards.

·         Support the preparation, coordination, and management of regulatory agency inspections. 

·         Proficient with mfg operations and quality procedures to comply with regulations.

·         Responsible for the enforcement of quality standards and process controls.

·         Lead and/or respond to quality audits to assure conformance with regulatory and internal requirements. Has the skills necessary to conduct own internal audits.

·         Perform assigned work in timely and safe manner conforming to regulatory, company, and compendial requirements.

·         Maintain a working knowledge of government and industry Quality standards.

·         Provide direct mfg QA support during internal/external regulatory inspections.

·         May Participate in QRB and other compliance meetings for ensuring compliance requirements are met.

·         Participate in the development and delivery of internal training programs.

·         Hire, mentor and train staff and implement good performance management practices.

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

·         Bachelor’s degree in Chemistry, Life Science, or related field required.

·         10+ years’ in a cGMP/pharma environment or equivalent; 3+ years’ related aseptic manufacturing experience.

·         4+ years’ supervisory experience required.

·         Experienced in training techniques.

·         Experience in sterile product, quality assurance, quality control or packaging operations. 

·         Prior experience with regulatory (FDA) inspections.

·         Solid understanding and use of ANSI sampling techniques and principles.

·         Intermediate principles of mathematical and statically computations.

·         Must have proficiency in cGMP/GLP practices in a FDA regulated environment.

·         Must have SOP, investigation, and project protocol writing skills.

·         Must have an understanding of cGMPs, GLP, CFR, ISO and USP.

Preferred Qualifications 

·         Able to analyze and troubleshoot problems.

·         Able to effectively handle conflict/resolution situations between different departments and intra-department.

·         Ability to interpret quality standards for implementation including ability to manage systems or processes.

·         Ability to make sound decisions about scheduling, providing direction allocation of resources, managing priorities and work hours to meet business objectives. 

·         Flexibility in problem solving and solid decision making skills.

·         Ability to lead moderate to complex projects or systems.

·         Must have good verbal and written communication skills

·         Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.