Sr Manager, QA

Kelly Services; Malvern (Chester County); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

PTO & holidays

401K

Job summary

Kelly Science & Clinical is seeking a Sr Manager, Quality Assurance for an engagement in the Greater Philadelphia area. The role oversees QA activities to ensure GLP, GCP, and 21 CFR Part 11 compliance, leading a team and coordinating audits. Competitive benefits and direct hire opportunity.

Location: Greater Philadelphia, PA. Mon-Fri 8AM-5PM; salary $110,000-$120,000 with 401K, PTO, and medical benefits.

Qualifications

• BS degree in Life Sciences or related field; advanced degree preferred.
• 10+ years of progressive QA in clinical research; CRO experience preferred.
• Strong knowledge of GLP, GCP, and 21 CFR Part 11.
• 5+ years of managerial or supervisory experience in a regulated QA environment.
• Excellent verbal and written communication; leadership and team-building skills.

Responsibilities

• Applies strong understanding of GLP, GCP and 21 CFR Part 11 regulations to QA work.
• Leads QA team and promotes a culture of quality and collaboration.
• Leads risk-based audits of quality systems, study processes, and data.
• Reviews SOPs and quality systems for compliance; facilitates CAPA resolution.
• Hosts client audits and regulatory inspections as needed.
• Trains, mentors, and coaches QA staff; develops SOPs and training.
• Develops and measures quality metrics for GCP/GLP activities.
• Reviews/approves quality documentation per SOPs and regulatory requirements.

Skills

GLP/GCP knowledge

Regulatory compliance

Leadership

Communication skills

Quality systems

Education

B.S. Life Sciences or related

Advanced degree preferred

Job description

Sr Manager, Quality Assurance

Kelly Science and Clinical has an opening for a Sr Manager, Quality Assurance for an engagement at one of our leading pharmaceutical clients in the Greater Philadelphia area. The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, and 401K. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Schedule

Mon-Fri, 8AM-5PM

Location

Greater Philadelphia, PA

Duration

Direct Hire

Compensation

$110,000-$120,000

Position Summary

Ensures that the facility operates in compliance with applicable GLP (FDA, EPA and OECD), ICH GCP, and 21 CFR Part 11 regulatory requirements and company SOPs. Provides leadership of the Quality Assurance team, promoting a positive culture of quality improvement, collaboration, and team development. Leads risk-based audits of quality-related documentation and procedures both internally and externally. Analyzes compliance trends and quality issues. Serves as site Quality SME.

Key Responsibilities

• Applies strong understanding of GLP (FDA, EPA and OECD) and GCP regulations, as well as 21 CFR Part 11 (electronic records and electronic signatures), as applicable to the work of the company.
• Promotes a positive culture of quality improvement and collaboration within the QA team and with other teams.
• Leads and conducts risk-based audits of quality systems, study processes, facility operations, experimental data, testing records, study reports, and other regulated activities according to applicable SOPs, as well as external vendor audits.
• Reviews company SOPs and quality systems for compliance, adequacy, and completeness. Facilitates laboratory investigations and CAPA resolution.
• Hosts/leads client audits and regulatory agency inspections, as needed.
• Trains, mentors, and coaches QA staff.
• Assists with the development of SOPs.
• Oversees/leads in-house compliance training.
• Provides quality and compliance advice to company personnel.
• Develops and measures quality metrics to drive consistent quality standards relating to GCP and GLP activities.
• Reviews and/or approves quality-related documentation in accordance with SOPs and applicable regulatory requirements.

Qualifications

• BS degree in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, or related field required; advanced degree preferred.
• 10+ years of progressive quality assurance in clinical research with CRO experience preferred.
• Strong knowledge and understanding of the requirements and applicability of GLP (FDA, EPA and OECD), GCP, and 21 CFR Part 11 (ERES).
• 5+ years managerial or supervisory experience in a regulated Quality environment.
• Proven leadership with strong organizational and team-building skills.
• Excellent verbal and written communication skills.
• Strong knowledge of pharmaceutical/biotechnology and agrochemical industries
• P#1

Benefits

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type.

• 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.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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 may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affinity 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.