Senior Manager, Quality Control Systems Templating

As Senior Manager in the Quality Control organization, youre in a leadership position with responsibilitiestosuperviseandmentorstaff. Asaleader,youwillfocusyoureffortsonthefollowingfunctions in support of global QC systems operations:

Roles & Responsibilities:

• Oversight of the AIN-based QC Systems team in support of QC system master data creation, management and qualification

• Collaboration with the global business process owner(s) to resolve issues encountered by the team

• Management of request prioritization in alignment with QC network needs

• Maintaining alignment between sites on use of QC systems and driving further standardization of testing documentation

• Collaboration with other global and site-based QC teams to achieve QC network goals

• Supportstafftraining,careerdevelopmentandperformancemanagement of team across all three shifts

• Responsibleforensuringcompliancewithsafetyguidelines,cGMPsandotherapplicable regulatory requirements

• Champion process improvements to increase efficiency and productivity

• Assign workload appropriately and strategically based on required interactions with sites in the QC network across multiple timezones

Thefollowingaresomeexamplesoftasksfortheposition

• Evaluate master data requests and categorize based on complexity

• Assign requests taking into consideration priority, network alignment and requested completion timelines

• Track progress of requests in alignment with due dates, and course correct as necessary

• Escalate roadblocks faced by the team to avoid impact to achieving targets

• Applyanalyticalskillstoevaluateandinterpretcomplexsituations/problemsusingmultiple sources of information

• Anticipateandpreventpotentialproblems with engagement in the network of knowledge sharing in near misses

• Provide updates to the global QC networkonmetrics,analyzingdataand recommending improvements

Basic Qualifications and Experience:

Mastersdegreewith 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience.

In addition to meeting the above requirement, you must have a minimum of 5-7years experiencedirectlymanagingpeopleand/orleadershipexperienceleadingteams,projects,programs,or directingtheallocationorresources.Yourmanagerialexperiencemayrunconcurrentlywiththerequired technical experience referenced above.

Functional Skills:

• Strongprojectmanagementskillsandexperiencesupervisingprofessionals in a Quality organization working with cross functional and global stakeholders across multiple time zones

• WorkingknowledgeofcGMPregulations,practices,andtrendspertainingtoQuality Control

• Experiencewithvariouslaboratorycomputersystems, equipment/instrumentation, andapplications

Soft Skills:

• Excellent written and verbal communication skills, ability to work in a team environment and build relationships with partners

• Track record of building and maintaining a high performing team

• Strong leadership and negotiation skills with a demonstrated ability to influence others

• Demonstrated innovative thinking and ability to transform work organizations

• Demonstrated ability to navigate through ambiguity and provide structured problem solving

• Demonstrated ability to deliver right the first time on schedule in accordance with established Service Level Agreements

• Demonstrated skills in staff motivation, coaching/mentoring and professional development