Product Quality Lead

Alkermes

1d•Remote

About The Position

This function is responsible for managing workflow within and outside Development and External QA. This function resolves and supports day to day events between internal (Alkermes) and external (CMO) stakeholders. This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside the area of responsibility. Minimal travel required to support job function (potential for one trip per quarter in a year).

Requirements

Must have a valid US Driver's License
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
Ability to increase others knowledge of US and European GMP regulations.
Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
Experience in participating in pharmaceutical technology transfer teams.
Experience in the qualification of facilities, utilities, equipment and processes.
Has a thorough understanding of the technology, processes, people and equipment of the plant site.
Has a thorough understanding of the regulatory process from GLP through commercial manufacturing.
Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
Ability to utilize knowledge and interpersonal skills to provide leadership, direction, and development of others.
Strong written and oral communication skills.
Teacher level knowledge of GMP's.
Requires a Bachelor’s degree in a scientific discipline or equivalent
Minimum of 8 years’ experience in a Quality Assurance role in the pharmaceutical industry

Nice To Haves

Experience in API manufacturing, packaging, aseptic processing and powder filling operations desired.

Responsibilities

Participates as appropriate in management of processes for quality and compliance.
Supports the development and maintenance of Quality Systems for Development and External Quality
Responsible for the monitoring of compliance with the requirement of GMP for internal and external stakeholders
Authority to approve or reject, as seen fit, drug product and finished goods product
Authority to approve or reject written procedures, master batch records, specifications, change controls, validation documentation and vendor document to support internal Alkermes requirements and external CMO requirements
Authority to review and approve deviations and high-level investigation reports (internal to Alkermes and in support of CMO investigations)
Responsible for the evaluation of batch manufacturing and control records
Support and/or lead small teams in the execution of complex, non-routine work assignments for project and/or continuous improvement initiatives.