Senior Quality Manager

Job Description

JOB TITLE: Sr. Quality Manager       

LOCATION: 1 Harbor Street, Boston, MA 02210

OPENINGS: 1

DUTIES:

• Responsible for providing quality oversight and support to manufacturing operations;

• Responsible for commercial and clinical batch disposition;

• Approves clinical and commercial lot COAs, generating BSE/TSE statement and product labelling;

• Evaluates investigations and other quality systems to support disposition;

• Provides production floor support and guidance for GMP product quality and compliance for product release;

• Provides QA support for development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks;

• Reviews and approves manufacturing documents including MCR, MBR, Recipe, and Engineering Parameters;

• Archives batch records and other supporting documents in electronic Document Management System;

• Monitors and tracks performance metric and trends;

• Serves as document owner for cross-GxP process, identifies risks, and communicates any gaps for quality processes optimization;

• Establishes and supports new product introduction into the Drug Product Facility including cross contamination strategy;

• Supports internal process validation activities and evaluation of process controls;

• Participates in inspection readiness activities and provides support during regulatory site inspections;

• Leads compliance walkthroughs of the site and helps drive the closure of any observations;

• Leads work process optimization, continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources;

• Responsible for biennial review and approval of department and cross-departmental processes for continuous improvement;

• Oversees excipient vendors and component distributors’ Quality Agreements;

• Establishes strategic goals for the team in line with Quality's overall goals and vision;

• Monitors GxP regulations and participate in updating QS policy statements;

• Coordinates Site Operation and QLT action items assigned;

• Participates in process improvement initiatives and performs gap analysis and risk communication;

• Participate in Material Review Board meetings; and,

• Supports GMP topic specific training program development.

REQUIREMENTS: Employer will accept a Bachelor's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices or a related scientific or allied health field and 5 years of experience in the job offered or in a GMP Operational Quality Manager-related occupation.

Position also requires 60 months of experience in the following:

Providing QA support and oversight of GMP manufacturing operation including batch release; Drug product development and manufacturing with proficient knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical setting: Using equipment, facilities and utility system qualifications activities in a cGMP setting; Leading event investigations, Root Cause Analysis (RCA), and CAPA; Network based applications such as Oracle, MES, and Veeva.

CONTACT: Send Resume to Sarah Hadjian at [email protected]. Reference 12140.521. EOE.

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Flex Designation:

On-Site Designated

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]