Manager, QC Tech Group

^Summary

Lead a high performing team of Quality Control staff that demonstrates a commitment to Quality goals and initiatives. Drive the activities and performance of staff to successfully meet requirements, laboratory quality, efficiencies, and improvements, and ensure cGMP compliance. Act as QC representative on various initiatives, projects, and committees. Apply extensive technical expertise and quality ingenuity to complex issues. Guide the successful completion of team on major programs/projects, may function in project leadership role.

^{Area Specific Requirements}

Oversee QC Tech Group supporting LIMS, CDS, SRB, and QC department testing of incoming materials, solutions, in-process and finished products, stability studies, and assessment of results. Provide product manufacturing and project/validation studies support. Requires flexibility to accommodate changes and priorities.

• QC Tech Group: Performs equipment qualifications/troubleshooting/decommissioning, method improvements/ validations (lead by MTD), QVAs. Responsible for CDS and LIMs administration and efficiency/use improvements (working w/IT). Serve as technical & lead SMEs on projects, programs, & committees (e.g. Specification Review Board (SRB) covering specifications, stability (including inventory mgt), compendial changes, other). Write annual invalids assessment report, assesses OOA/OOTs (working w/statistician). Verify and approve data as needed. QC Tech Group supports QC teams cross-functionally, and works regularly with other Quality teams, Tech Ops, and Regulatory.

^{Key Responsibilities/Essential Functions}

• Manage staff, tasks and objectives to successfully deliver a reliable supply of product, meet area specific requirements. Advise on tasks, projects, and operations. Become actively involved in operations as required to meet schedules or to resolve complex problems.
• Ensure equipment is qualified, and methods are current and validated/verified. Ensure that QC testing, recording, collection, review/approval and maintenance of data, are performed in accordance with SOPs, cGMPs, company standards, policies and regulatory requirements. Manage individual and group performance to meet internal policies and requirements, ensuring work is performed in a quality, compliant, and timely manner and meets business priorities/objectives. Monitor and report metrics and trends.
• Ensure appropriate use of a wide range of electronic systems such as ERP, QMS, LIMS, CDS, and equipment software. May be administrator for area-specific software systems and on notifications for alarm response (e.g. temperature units).
• Manage team for high performance and accountability. Includes staffing, training, reviews, balancing workload schedules, and driving continuous compliance, process, and efficiency improvements. Develop and action plans to further enhance technical skills and overall competencies of staff members that contribute to succession plan and risk reduction for quality Allocate time effectively for employee development and coaching. Lead staff to achieve professional growth and attain established goals.
• Liaison with departments at various management levels regarding operations and projects. Independent positive leader with strong communication and solid interpersonal skills. Provide direction to team, act on issues, make decisions, monitor, and report on progress. Utilize meetings effectively, facilitate/drive team VPM efforts, participate in GEMBA walks, and use Lean/PM tools as appropriate.
• Interpret and execute policies and procedures that typically affect subordinate organizational units/staff, recommend modifications if needed.
• Responsible for team resource planning, effective Budget/CapEx planning, implementing cost savings, and ensuring expenditures are aligned.
• Oversee team's timely use of quality management systems (QMS) such as training, investigations, deviations, CAPAs, SOP reviews/revisions, change controls, and protocols. Take main and/or reviewer roles (e.g. lead investigator, SOP business owner, change control author, protocol studies). Resolve routine, non-routine and advanced problems independently by utilizing problem solving and technical skills and partnering with appropriate resources.
• Represent Quality Control and/or area department(s) on a range of initiatives, projects, committees, and update/planning meetings, providing area perspective and expertise. Drive accountability for meeting requirements.
• Maintain and demonstrate knowledge of current relevant US and global regulatory requirements/guidelines (e.g. cGMP, FDA, USP/EP/JP ). Update internal procedures to ensure Extensive/advanced knowledge of industry practices for assigned area including specialized functions/technology, concepts, techniques, and standards. Ensure inspection readiness of area/processes. Interface with external regulatory inspectors and internal compliance auditors. Ensure timely completion of any commitments made.
• Requires a wide and comprehensive acquaintance with, and understanding of, both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered. Serve as area expert in field within the organization, also leverage other experienced staff SMEs.
• Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and takes initiative to correct safety & environmental hazards. Oversee staff who work with (or in proximity to) potentially hazardous chemical, radiological, and/or biological materials to ensure a safe working environment.
• Actively demonstrate the values of accountability, quality, customer service, efficiency, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others. Help people be their best. Respect one another and act as one. Own the solution and make it happen. Learn, adapt and win. Know someone's health is in our hands.

^{Basic Requirements}

• Typically requires min. 7-10 years' experience with a BS in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
• Current knowledge of industry best practices and procedures for QC labs and applicable regulatory Previous experience with and knowledge of manufacturing processes, experience with budget planning and cost containment, Lean, and project experience preferred.

^{Other Requirements}

• Flexibility with scheduling requirements for staff and manager support of them may include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions. Some non-routine travel may be required.
• Manage and direct staff who work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and who must be able to lift/move a variety of materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals, waste containers.