Site Quality Lead - Pharmaceutical - Part-time

Job Title: Site Quality Lead

Location: Royersford, PA

Part-Time: 15-20 hours per week as and when required (Prior intimation will given when required ) with potential to full time or permanent part-time

Job Summary: The Site Quality Lead for company’s Royersford, PA facility is member of the PRG site leadership team and will oversee all Quality operations for the Royersford facility, assuring compliance with all applicable GxP regulations in the markets required by our clients. This Lead will provide direction, leadership and development to the Quality Assurance/Control and Operations staff, and will develop, maintain and continuously improve the Quality System to assure conformance with all GXP’s and regulatory requirements.

Key Responsibilities:

• Quality Management:
• Serve as the site head of Quality for Company’s Royersford facility
• Assure cGMP and regulatory compliance with all FDA and applicable external US regulatory requirements and guidance documents within company and its vendors.
• Direct and assure all company Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
• Manage all FDA and other regulatory agency activities including facility inspections, inquiries, notifications, all and other agency associated activities.
• Develop, implement, and maintain quality assurance processes and systems, including but not limited to:
• Maintain supplier qualification and management program
• Manage the document management system, including writing and revising and maintaining SOP's, SOP track tracking and SOP training
• Manage/Perform market distribution of batches, including batch documentation review
• Manage the review and resolution of batch deviations, out of specification(OOS) reports and proposed corrective and preventative actions (CAPA).
• Perform product quality reviews including the review of manufacturers reports of annual product reviews
• Manage/Perform change control review
• Conduct regular internal and/or external audits and inspections to ensure adherence to quality standards.

o Ensure overall site inspection readiness.

• Team Leadership:
• Lead and manage the site quality team, including recruitment, training, and performance management.
• Foster a culture of continuous improvement and quality excellence.
• Risk Management:
• Conduct quality risk assessments and develop mitigation strategies.
• Oversee the investigation and resolution of quality issues and non-conformances.
• Documentation and Reporting:
• Ensure accurate and timely documentation of quality activities.
• Prepare and present quality reports to senior management.
• Collaboration:
• Work closely with cross-functional teams, including production and R&D, to ensure quality objectives are met.
• Act as the primary point of contact for quality-related matters at the site.

Qualifications:

• Education: Bachelor’s degree in a technical discipline preferred – for example, Engineering, Pharmacy, Chemistry, Biology, or a related field.
• Experience: Minimum of 6-10 years of experience in quality assurance within the pharmaceutical or medical device industries, with at least 5 years in a manufacturing leadership role.
• Experience leading the Quality interface with clients in an FDA/ cGMP environment
• Experience with Quality Management System implementation and continual improvement
• Proven track record of managing complex Quality investigations (root cause analysis), managing risk and being results driven and capable of rapid decision making to meet both business and Quality needs
• Proven experience leading inspections of regulatory agencies
• Strong knowledge of cGMP, FDA regulations, and other relevant standards.
• Experience with solid oral/liquid dose manufacturing and in Quality, Operations or Tech Ops roles
• Knowledge of Process and System Validation/Qualification
• Excellent leadership and team management skills.
• Strong analytical and problem-solving abilities.

Additional Requirements:

• Ability to work in a fast-paced, dynamic team environment.
• Strong attention to detail and commitment to quality.
• Effective communication and interpersonal skills.
• Proficiency in quality management software and tools.

Job Type: Part-time

Pay: $36.00 - $40.00 per hour

Expected hours: 15 – 20 per week

Schedule:

• Monday to Friday

Ability to Commute:

• Royersford, PA 19468 (Required)

Work Location: In person

Salary : $36 - $40