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 is a multi-faceted role. The individual will work with a variety of technical professionals including manufacturing, engineering (e.g. facilities, process, systems), validation, analytical laboratories and microbiology.

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 Senior 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 Senior 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.

The candidate is expected to be a subject matter expert (SME) in compliance, auditing, proper documentation practices/requirements, GMP laboratory practices, training, and industry guidance standards. The candidate will provide the needed support to host regularly scheduled Quality Council meetings and the Investigation Review Board meetings.

Requirements

This positions responsibilities will include, but not be limited to the following:

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.

30% Auditing

• Develop a risk based internal audit program.
• Ensure a state of inspection readiness to host and support regulatory authority inspections.

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 APRs 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).

Benefits

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays