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.

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