QA Manager – Langhorne, PA

The Manager of Quality Assurance works in a fast-paced, FDA-regulated, aseptic manufacturing environment directly supporting initial qualification, documentation, and impending commercial readiness of a new aseptic manufacturing plant that will produce sterile products.

This position reports directly to the Director/Site Head of Quality Assurance and will manage direct reports within Investigations/Customer Complaints, Change Control, Auditing and Laboratory oversight groups. This position ensures timely support of the needs of the manufacturing, laboratory and validation groups. The Manager of Quality Assurance will audit the GMP aspects of the individual departments and will instill compliance knowledge throughout the site. This position manages the Investigation Review Board, reports and maintains appropriate site quality performance metrics. The Manager of Quality Assurance will ensure that any proposed changes are assessed to determine their impact on the existing qualified state as well as their GMP impact.

Key Duties & Responsibilities:

40% Laboratory Oversight

Manage test method review, data trending, and logbook review.

• Interface with MODA and LIMS to ensure that data is meets specifications and is recorded in accordance with Good Documentation Practices and ALCOA principles.
• Support all Laboratory Investigation Records and any laboratory improvement initiatives (SOP revisions, management of change records, laboratory related qualifications).
• Monitor and improve systems with key metrics.
• Manage the QA retain sample program.

30% Auditing

• Develop a risk based internal audit program.
• Ensure a state of inspection readiness to host and support regulatory authority inspections.
• Track and trend CAPAs associated with audit observations.
• Manage the external supplier / vendor qualification audit program.
• Provide guidance during routine operations to ensure continuous compliance with procedures and regulations.

30% Compliance Support

Manage the Customer Complaint system for both product and adverse event complaints; ensuring investigations are performed on time and any notifications meet regulatory reporting requirements (i.e. Field Alert Reports (FARs), 3 day and 15 day alerts, etc.).

• Oversee the routing, tracking and approvals of Change Controls, CAPAs and Deviation Reports (OOS, OOT, Manufacturing, Customer Complaints)
• Manage the collation and generation of Annual Product Reviews (APRs); ensuring the timely approval of all APR’s and the continued improvement of the generation process and the effectiveness of the utilization of report contents and data.
• Administer Deviation Investigation, CAPA and Change Control systems
• Maintain Metrics for reporting Lot Acceptance Rate (LAR), Product Quality Complaint Rate (PQCR) and Invalidated Out-of-Specification (OOS) Rate
• Maintain on-going metrics for Annual Product reviews, including RFT (Right First Time), and Batch Record Error Rates by error type and process, and assessing alert and action limits based on sound statistical tools (continuous process capability).

Qualifications: Bachelor’s degree in related field preferred

• 5-10 years of Aseptic Sterile QA management experience
• 2+ years of previous of QA management/supervision experience
• Must possess strong communication and technical writing skills
• Preparation, approval of SOPs, Quality Risk Management for process, area, and equipment
• Assist with quality improvement initiatives
• Working knowledge of Word, Excel, PowerPoint, Visio, Electronic Quality Management System(s)
• Experience with electronic document management systems (Documentum, LIMS, MODA, Master Control, etc.)