Associate Director, QA

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

Benefits offered by this job

Medical benefits

Paid time off (PTO)

Holidays

401K

Job summary

Kelly Science and Clinical has an opening for a Sr Manager, Quality Assurance for a leading pharmaceutical client in Chester County, PA. The role leads the Malvern QA team, ensuring GLP, GCP, and 21 CFR Part 11 compliance and driving continuous quality improvements.

You will lead risk-based audits, mentor staff, coordinate client audits, and develop quality metrics, with a competitive benefits package and a direct hire arrangement.

Qualifications

• BS degree in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, or related field required.
• 10+ years of progressive quality assurance in clinical research with CRO experience preferred.
• Strong knowledge and understanding 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.
• Strong knowledge of pharmaceutical/biotechnology and agrochemical industries.
• P#1

Responsibilities

• Applies strong understanding of GLP and GCP regulations, as well as 21 CFR Part 11, as applicable to the work.
• 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.
• 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.

Skills

Regulatory knowledge GLP/GCP/21 CFR 11

Leadership/people management

Auditing and CAPA leadership

Quality assurance in clinical research

Communication skills

Education

BS in Life Sciences or related field

Advanced degree preferred

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 Chester County, PA. 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.

Benefits

• medical benefits
• paid time off including vacation (PTO)
• holidays
• 401K

Schedule

Mon-Fri, 8AM-5PM

Location

Chester County, 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 Malvern 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