This function is responsible for managing workflow within and outside Quality Assurance. This function resolves and supports day to day events between direct reports and other areas within the Quality Assurance organization. This function also resolves and supports day to day events between Quality Assurance, other quality units and areas outside of quality. This function develops and implements tactical initiatives directed by Senior Management. This function communicates events to Management and thresholds events when they are outside of the area of responsibility.
Authority to approve or reject written standards, including Master Production Records, Standard Operating Procedures, Specifications, Sampling Instructions and Test Methods.
Authority to approve or reject, as seen fit, intermediate, bulk and finished products.
Participates as appropriate in management processes for quality and compliance.
Responsible for ensuring that all necessary testing is carried out.
Responsible for ensuring that the required initial and continuing training of direct reports is carried out and adapted according to need.
Responsible for investigations and monitoring of factors which may affect product quality.
Responsible for the evaluation of batch manufacturing and control records.
Responsible for the evaluation of written standards.
Responsible for the monitoring of compliance with the requirement of GMP.
Responsible for the supervision of direct reports.
Preferred Skills/ Abilities:
Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
Experience in participating in pharmaceutical technology transfer teams.
Experience in the qualification of facilities, utilities, equipment and processes.
Ability to increase others knowledge of US end European GMP regulations and guidance.
Strong written and oral communication skills.
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
Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development cross-functionally.
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 required, preferablywith parenteral dosage forms.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.