Sr Manager, QA

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

Benefits offered by this job

Medical benefits

Paid time off

Vacation

Holidays

401K

Job summary

Kelly Science and Clinical is seeking a Sr Manager of Quality Assurance for a top pharmaceutical client in the Greater Philadelphia area. This direct-hire role leads a QA team and ensures compliance with GLP, GCP, and 21 CFR Part 11, while driving continuous quality improvements.

The ideal candidate has a BS in Life Sciences and 10+ years in clinical QA with CRO experience, plus at least 5 years of managerial experience. Competitive benefits are offered, with PTO and 401K included.

Qualifications

• BS degree in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, or related field; advanced degree preferred.
• 10+ years of progressive quality assurance in clinical research with CRO experience preferred.
• Strong knowledge of GLP, 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.

Responsibilities

• Applies strong understanding of GLP, GCP and 21 CFR Part 11 to QA work.
• Leads QA team and promotes quality improvement culture.
• Leads risk-based audits of quality systems and study processes.
• Reviews SOPs and quality systems for compliance and adequacy.
• Hosts client audits and regulatory inspections as needed.
• Trains and mentors QA staff and develops SOPs.

Job description

Sr Manager, Quality Assurance

Kelly Science and Clinicalhas an opening for an 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 systems 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