Supervisor, Quality Program Management

Supervisor, Quality Program Management in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients.  At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer

+  Generous benefit options (eligible first day of employment)  

+  Paid training, vacation and holidays (vacation accrual begins on first day of employment)

+  Career advancement opportunities  

+  Education reimbursement

+  401K program with matching contributions

+  Learning platform

+  And more!  

The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor is responsible for fostering strong client quality relationships and ensuring the timely review and disposition of executed batch records (clinical, commercial, and media fills). This role works closely with cross-functional teams to monitor and support the stages of the batch disposition process, including manufacturing and quality reviews, to ensure deliverables are completed on schedule to meet supply commitments.

Key responsibilities include supporting the establishment, tracking, and improvement of batch record review and disposition cycle times. The role also involves coordinating shipments with the warehouse, participating in critical DEV review meetings to provide quality input, and contributing to the preparation of weekly and monthly metrics for senior leadership.  Additionally, the supervisor will assist with identifying and implementing process improvements and support other QA areas as assigned by QA management.

Essential Duties and Responsibilities:

+ Supervise and provide guidance to the QA batch record review and product disposition team

+ Support client Quality relationships through effective communication and timely deliverables

+ Review and assist in the disposition of executed Batch Records (Clinical, Commercial, & Media Fills) and collaborate with cross-functional teams to address review comments

+ Maintain the record review planner to track and monitor the stages of the batch disposition process, including manufacturing and quality reviews and quality disposition processes

+ Support efforts to monitor and improve batch record review and disposition cycle times

+ Assist in tracking metrics for the review and disposition process and provide input for monthly performance analysis

+ Oversee Disposition timelines and support client calls related to Disposition schedules and delays

+ Ensure timely responses to client comments on Batch Records

+ Coordinate with QC labs, external testing, and the deviations team to ensure all deliverables are completed on time to meet supply commitments

+ Coordinate shipments with the Warehouse (including Q Ships & Release Shipments)

+ Participate in critical DEV review meetings and provide quality input as needed

+ Contribute to the preparation and presentation of weekly and monthly metrics for leadership

+ Assist in developing batch record review training materials for Quality and Production teams

+ Review and provide input on SOPs related to the functional area

+ Support internal, client, and regulatory audits for batch record reviews

+ Identify process improvements and assist in their implementation

+ Provide support in other QA areas as assigned by QA Management.

+ Read/interpret SOPs to ensure compliance

+  Maintain up to date trainings

+  Other duties as assigned

Education and Experience:

+  Bachelor's degree in in Science, Chemistry, Biology or related field of study

+ Minimum of three (3) years in Quality Assurance or Regulatory Compliance Management

+ Minimum of two (2) year in a leadership role

+ Minimum of three (3) years in an aseptic/sterile product facility, preferred

+  Knowledge in current regulations (21

CFR, Annex 1 etc), preferred

Supervisory Responsibilities:

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures.
This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language

Skills:

The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients,…