Associate Director of Quality Assurance Operations

Kelly Science & Clinical is seeking an Associate Director of Quality Assurance Operations for one of our clients, a biotech company, located in Houston, TX.

Responsibilities:

• Ensure line-clearance/ change-over activities are executed.

• Oversee the disposition, hold, or rejection of raw materials, starting materials, in-house prepared materials, intermediates, and drug products.

• Ensure the generation and reconciliation of in-process and Drug Product labels is performed with compliance aspects being met.

• Ensure the review and approval of executed documents related to manufacturing operations, QC, and other departments is performed with compliance aspects being met.

• Initiate, author, review and approve deviations, CAPAs and Change Controls associated with Quality Operations practices as well as other departments.

• Create, review, and approve procedures and practices within Quality Operations to implement company quality standards.

• Partner with other departments to implement, optimize, review, and approve batch records, practices, and procedures.

• Accomplish quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.

• Develop quality assurance plans by conducting hazard analyses and monitoring procedures.

• Achieve quality assurance operational objectives by contributing to information analysis.

• Validate quality processes by establishing product specifications and quality attributes.

• Maintain and improve product quality by completing product, company, system, and compliance audits.

• Train and motivate employees on Quality Operations procedures and practices to ensure quality standards are met.

• Lead and manage a team of quality professionals, directing them toward achieving goal-oriented tasks.

• Support the recruitment process by assisting in the identification, selection, and hiring of qualified candidates.

• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in scientific field.

• 12+ yrs. related experience in QA.

• 6+ yrs. managerial experience, preferably within QA.

• Understanding of Cell and Gene Therapies.

• Demonstrate expertise in multiple QA related areas; SME in specific areas related to operations.

• Understanding of cGMPs, GLPs and GXPs.

• Knowledge of local and global regulations.

• Excellent verbal and written communication skills.

• Excellent interpersonal and customer service skills.

• Excellent organizational skills and attention to detail.

• Excellent time management skills with a proven ability to meet deadlines.

• Strong analytical and problem-solving skills.

• Strong supervisory and leadership skills.

• Proficient with Microsoft Office Suite or related software.

Job Details:

• Direct Hire

• Monday-Friday, day shift

• Pay rate dependent upon level of education

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.