Senior Specialist, GMP Operational Quality (Onsite)

Job Description

The Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. 

The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Senior Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs.

The position will support multiple production functions (from Quality operations to Quality Engineering) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by applying the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with a cross-functional team, as needed. Advising Production on proper documentation as needed and performing other duties as assigned.

This role will require local presence at the VMC, Boston site.

Key Leadership Skills:

• Cross-functional collaborator

• Results Driver

Key Knowledge/ Skills and Competencies:

• Strong leadership skills with the ability to thrive in a high throughput environment

• Critical Thinking / Problem-Solving

  • Ability to evaluate quality matters and make decisions

• Strong oral and written communication skills required

• Good Interpersonal skills required

• Attention to detail

• Knowledge in the following areas:

  • Knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices

  • Ability to work under limited supervision

Oversight of Internal Operations – QA Operation and Compliance

• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.

• Lead, mentor, and coach Operations and support personnel on quality matters, while driving the site Quality culture.

• Ensure regular presence in GMP operations areas as needed. Approves line, and area clearance.

• Review and approve batch production records and other GMP documentation in support of daily operations.

• Review and approve Deviation, CAPA, and Change Control records.

• Support performance metrics, trends; including site metrics for investigation/CAPA, Equipment and Facility Change Controls, etc

• Participate in self-led inspections and provide support during internal/external regulatory inspections.

• Responsible for identifying risks and communicating gaps for GMP process/systems

• Support Lean Transformation and Operational Excellence initiatives

• Adhering to safety rules and maintaining a safe work environment for both you and others by supporting EHSS corporate and site goals

• Serves as a trainer for junior hires.

Oversight of Internal Operations – Quality Engineering

• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications

• Review and approval of qualification activities, and periodic assessments, trending programs (equipment, facility, utilities, etc.)

• Support EM and UM programs and control programs (Veriteq, pest control)

• Provide support for facilities and engineering projects, including capital projects, annual plant shutdowns, and various improvement projects as assigned

Audit / Inspection Support

• Participate in inspection readiness activities and provide support during regulatory site inspections.  Provide post-inspection support to address any regulatory observations.

Deployment of QMS and Establishment of Compliance Expectations

• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.

• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate the resolution of quality issues in a timely manner.

Individual Development and Training

• Responsible for timely completion of trainings (100% on-time), goal development, self-evaluation and IDP