QA Senior Manager - 33670 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Gates Biomanufacturing Center

Job Title: QA Senior Manager

Position #: 00803572 – Requisition #:33670

Job Summary:

Key Responsibilities:

• Manage the day-to-day operations of quality assurance priorities, batch disposition, client interactions, and any product investigations.

• Manage three direct and four indirect reports, including Quality Assurance Associate Is and IIs.

• Recruit, supervise, develop, and mentor members of the Quality organization including the creation of professional and personal development plans, and yearly performance reviews.

• Takes an active role in planning and implementation of QA long-range goals for further development of key QA initiatives.

• Serve as the QA point of contact in CMC and Process Development and direct QA functional areas to facilitate the onboarding and approval of therapeutic product to clinical trials.

• Establish, author, review and approve Facility standard operating procedures (SOPs), Quality Policies and Quality Agreements.

• Understand and navigate the complexities of a multifaceted environment.

• Interact and influence decisions of Directors from Cell Therapy, Supply Chain, Finance, and Protein Biologics departments to optimize facilities, both on and off campus, to ensure efficiency of operations.

• Guide in-process, bulk drug substance and final product batch release efforts including master and executed batch record review/approval, material disposition, and shipment of product to local and national clinical sites.

• Provide site-wide guidance for deviations, Out of Specification (OOS) investigations, corrective/preventive actions (CAPAs) and change control implementation. Review and approve deviation investigations and CAPA plans.

• Leads the preparation of regulatory inspections and external audits and represents GMP Quality in inspections and audits.

• Administrate and conduct internal and external audits. Responsible for the scheduling and completion of client and vendor audits.

• Develop QA Key Performance Indicators (KPI) metric reporting system and coordinate reporting to Facility management and University representatives.

• Review IND applications, CMC, Facility Master File submission as needed and support Associate Director Quality in maintaining Facility Master File

Work Location:

Why Join Us:

Diversity and Equity:

Qualifications:

Minimum Qualifications:

• B.S. in a Biological Science. Substitution: A combination of education or related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

• 6+ years combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device, or analytical testing environment (FDA regulated industry).

Applicants must meet minimum qualifications at the time of hire.

Condition of Employment

• This position may require weekend work and work outside of normal work hours to accommodate the completion of release testing or other critical processes which cross shifts. While not typical, this irregularity of work hours should be expected.

• During manufacturing audits, this role may be exposed to noise and vibration.

• Work environment may expose individuals to hazardous chemicals, infectious materials, recombinant DNA, or human blood or bodily materials.

Preferred Qualifications:

• A Master's degree in scientific discipline, Biological Sciences, or a related field.

• 10+ years combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, devices, or analytical testing environment (FDA regulated industry).

• 2+ year experience working in Quality Assurance group in a GMP pharmaceutical/biologics or cell therapy contract manufacturing setting.

• 2+ year of supervisory or mentoring experience.

• Experience with the implementation and management of an electronic Quality Management System (e.g., Trackwise, Documentum, etc.) is highly desirable.

• Experience with phase appropriate analytical development and assay qualification.

• Experience with Facility qualification and engineering.

Competencies/Knowledge, Skills & Abilities:

• Strong organization and project management skills; able to perform/lead a variety of tasks, planned and unplanned with an exceptionally high level of quality under timelines.

• Ability to recruit, develop and retain a high performance, results-oriented team within a collaborative environment.

• Ability to communicate effectively, both in writing and orally.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

• Outstanding customer service skills.

• Demonstrated commitment and leadership ability to advance diversity and inclusion.

• Proficient with common software applications/programs (MS Word, Excel, Powerpoint, etc.)

• Capable of working as an individual or in a team setting.

• Motivated self-starter capable of operating in a start-up environment.

• Highly effective communication and interpersonal skills (formal/informal); able to communicate and work with all levels of the organization and University administration.

• Ability to influence, self-sufficiency, effective time-management.

• Self-starter, detail-oriented, flexible, professional, can-do attitude required.

• Must be able to work with little supervision and use independent judgment.

• Ability to work well with people and project a professional image to vendors and coworkers.

• Ability to work in a fast-paced environment.

• Strong interpersonal and communication skills.

• Demonstrated commitment and leadership ability to advance diversity and inclusion.

How to Apply:

1. Curriculum vitae / Resume

2. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Screening of Applications Begins:

Anticipated Pay Range:

or hiring range

ADA Statement:

Background Check Statement:

Vaccination Statement:

Job Category

Primary Location

Schedule

Posting Date

Unposting Date

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This position is a full-time, management-level position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Quality Assurance team. This position will be responsible for working closely with the Director and will manage QA personnel and the day-to-day operations of the GBF QA team, quality system implementation, investigations, client onboarding, and analytical process development. This position will actively support the development and implementation of QA strategic goals and initiatives and serve as a QA main point of contact.

Onsite – this role is expected to work onsite and is located in Aurora, Colorado

The opportunity offered by the Gates Institute is one of a kind. They blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus – the University of Colorado – Anschutz Medical Campus. The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. They are only limited by their resources and need you to make their journey a success! In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=https://www.cu.edu/employee-services/benefits-wellness) . The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Experience in managing the release and distribution of bulk drug substances and finished products to support early stage (i.e., Phase I and Phase II) clinical trials.

For full consideration, please submit the following document(s): Questions should be directed to: Chandresh Undhad, Chandresh.undhad@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=Chandresh.undhad@cuanschutz.edu)

Immediately and continues until position is filled. For best consideration, apply by June 30, 2024.

The starting hiring range for this position has been established as $100,746 – $128,149. The above salary range () represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=http://www.cu.edu/node/153125)

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=hr.adacoordinator@cuanschutz.edu) ​.

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .

Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 21796 - ADM CHAN GBF Spnsrd/Gift : Full-time : May 17, 2024 : Ongoing Posting Contact Name: Chandresh Undhad Posting Contact Email: Chandresh.undhad@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5268257&targetURL=Chandresh.undhad@cuanschutz.edu) Position Number: 00803572jeid-dc7693f41da90641a65e7d44bcb56ed6

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.