Manager QA (Drug Product)

We are currently looking to fill a Manager, QA (Drug Product Manufacturing) position. This position supports facility start-up and operations of a new internal aseptic drug product facility.

The position will be responsible for the first shift on the floor Quality Operation Team.

Available Working Schedule :

Monday-Friday, 8 : 00am-4 : 30pm

In this role, a typical day might include the following :

Builds and maintains a robust team of specialists by providing effective communication, motivation, mentorship, career development and performance feedback.

Lead cross functional teams and handles the results for the assigned projects. Drives projects through completion within timeline, quality and budgetary constraints.

Develops or supports program development for On the Floor Quality, Aseptic Qualification, Aseptic Process Simulation, and Filling batch records.

Develops functional processes, procedures and policies for areas. Works with senior management to report on project and program achievements and to present project needs.

Provides first response for Quality and Compliance issues on the manufacturing floor

Provides review and final QA approval of : Deviations, Change Documentation, CAPAs; SOPs; Electronic builds of Master Batch records

Interacts closely with Quality Systems, Manufacturing, Process Science, Manufacturing Science & Technology

Uses data trends to work with operating departments to facilitate process improvements.

Ensures product, facility, and equipment holds are placed when batch, equipment or system integrity is questioned

Ensures manufacturing quality staff are appropriately trained to support plant operations, ensuring risks are identified and resolved.

Ensures periodic formal and informal audits are completed in production

Directs the activities of resources, both internal and outside contractors / vendors, with similar technical or functional responsibilities.

Responsible for implementing operational and strategic policies and directives.

Ensures projects are on schedule and within budget.

Receives assignments in the form of general objectives with goals and processes defined.

Requires the ability to influence others to achieve results

Provide Leadership and direction to the manufacturing and support area departments to ensure a constant state of inspection readiness.

Accountable for ensuring policies, procedures, and standards are consistently followed and adhered to on a consistent basis;

and changes policies, procedures and standards as appropriate to ensure the highest quality standards are maintained.

This role may be for you if you :

Are able to set priorities within defined responsibilities and execute on results and goals per established timelines

Can adjust schedule based on facility start up, filling, and manufacturing needs.

Have strong decision-making skills

Possess the ability to multi-task and own multiple projects while ensuring each is progressing as planned

Excel at building relationships and working on cross functional teams

Are able to gown for an A classification clean room

To be considered for this role you must hold a Bachelor’s degree in Life Sciences and the following minimum amounts of experience in a Quality Operations, Quality Assurance or manufacturing role, in a late stage or early stage start-up Drug Product company for each level :

Associate Manager 6+ years

Manager 7+ years

Also requires 2+ years of work experience in a leadership role. May substitute proven experience for education requirement.

Level is determined based on qualifications relevant to the role.

REGNQA