Sr. Manager, Quality Assurance

Job Description

POSITION SUMMARY:

The Senior Manager of Quality Assurance is responsible for managing a staff of quality assurance personnel for day-to-day quality operations within the Quality Control (QC) (Analytical and Microbiology) laboratory operations. Assures Quality oversight of QC laboratory testing, and ensures testing meets applicable standards and regulations requirements for product and materials. Ensures adherence to facility quality systems such as batch review, product release, change control, deviation and CAPA management, and product annual reviews. Manages resources to ensure production cycle times are met for manufacturing, supply chain and client demands. Oversees the design, development and implementation of laboratory QA programs, and ensures all cGMP requirements, including review of QC data, lab investigation, and compliance to data integrity principles.

PRINCIPAL DUTIES:

· Manages quality assurance personal for day-to-day operations for QC labs.

· Manages, trains and develops direct reports.

· Manages resources in order to meet annual budget. Reviews new project requirements ensuring QA or QA project plans are prepared as needed.

· Manages resources to ensure adequate product/material cycle times are met in order to meet supply chain and client demands.

· Implements LEAN concepts to continuously improve cycle times within the area of responsibility.

· Partners with QC management in the areas of cGMP compliance and quality systems.

· Provides direction in the event of QC incidents that may potentially affect quality or compliance.

· Manages investigations, CAPAs, QC record review, product release CofA, Environmental Monitoring data, change control, requalification and product annual review in the QC area.

· Reviews and approves changes within the QC area including changes to process, equipment, procedures, and computerized systems.

· Reviews raw data, to verify that ALCOA++ principles are being followed, accurate and in control before reporting.

· Reviews control charts and records on instrument calibration and performance of known and blind QA samples as a measure of analytical precision and accuracy.

· Ensures compliance with current regulatory or product license requirements and cGMPs.

· Maintains appropriate records, certifications and training verification for ongoing laboratory programs and operations.

· Ensures that all applicable SOPs and QA Manuals are revised, updated, and implemented as required.

· Supports the Pyramid facility during external and regulatory inspections.

· Works directly with the investigators on defending facility quality systems and QC Lab investigations (e.g., OOT, OOS, etc.).

· Leads and performs technical write-up in support of deviation investigations pertaining to Lab QA Roles and Responsibilities.

· Performs other duties as assigned.

JOB REQUIREMENTS:

· Demonstrates proficiency in multiple quality systems including Deviation, CAPA and Out-of-Specification management, Change Control, Document Control, Product Testing Review and Release, Supplier Quality, etc. with strong decision-making skills utilizing risk management.

· Experience in all facets of QC operations including but not limited to utilities, raw materials, in-process, and final container testing.

· Strong biologics production experience

· Strong Materials/Component experience

· Lead multiple tasks/projects within timelines

· Strong verbal, written and oral communication skills. Able to present business indicators to senior management

· Strong knowledge of cGMP (US, EU, Canadian, Japan) required

· Strong knowledge of manufacturing processes, laboratory operations and/or critical systems required

· Able to present areas of responsibility to regulatory agencies during inspections

· Proficient in problem solving through the use of continuous improvement tools.

· Able to use continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent

· Able to manage employees, conduct performance reviews, establish development plans and manage resources

· Must have:

o Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

o Passion to innovate and drive for solutions.

o Uncompromising dedication to quality.

o Relentless focus on rapid and disciplined action.

o Respect for individuals and the diverse contributions of all.

o Must display personal accountability for results and integrity.

o Must display eagerness to learn and continuously improve.

· Must display

o Personal accountability for results and integrity.

o Eagerness to learn and continuously improve.

EDUCATION and/or EXPERIENCE:

· Bachelor’s degree in Sciences or Engineering.

· Minimum 10 years’ experience in Quality Operations function in a biotechnology, biologics, or pharmaceutical manufacturing facility, with 5 years’ experience overseeing Quality Control Lab QA functions.

· Minimum 8 years previous leadership, supervisory or management experience required.

· Quality Drug Product experience, preferred

Full-time