Job Title: QC Chemistry Manager

Work Location: Wake County, North Carolina

Summary:

The QC Manager will be responsible for leading a team that oversees all aspects of quality control at the facility. The duties of the QC Manager cover all aspects of QC, including but not limited to oversight of the Chemistry and Microbiology Laboratories analysis of Raw Materials, Manufacturing In-process Samples, Finished Product, Stability Testing, and Environmental Monitoring. Additionally, the QC Manager leads the Lifecycle Management group, oversight of Compliance records, the Product Stability Program, LIMS administration, Analytical Validation, and global / site-level strategic capital projects.

Primary responsibilities include leading, mentoring, and developing the chemistry & microbiology laboratory personnel in support of a cGMP sterile parenteral manufacturing facility. They are expected to lead by example and provide coaching to others in the areas of safety, quality, and Continuous Improvement/Lean methodologies (Lean Laboratory). Candidate needs to be capable of processing large amounts of information to make sound decisions in order to meet regulatory requirements of various agencies: FDA, EU, MHRA and internal/site KPIs. Must have a high degree of initiative to resolve problems, discuss and research actions to be taken, facilitate a “shared yes” across internal/external stakeholders, and ensure execution of solution(s).

Responsibilities:

• Responsible for microbiology and chemistry laboratory operations consisting of 15 - 25 individuals on various shifts, with multiple shift supervisors reporting to them.
• Responsible for Quality Record management (OOSs, deviations, change controls, CAPAs), LIMS administration, Capital Project Management, Analytical Validation, Reference Standard Certification, and Stability Program management.
• Identify and implement internal KPIs relating to Safety, Quality, Operational Effectiveness, Financial Performance, and Training while facilitating a culture that drives the behaviors required to meet metrics and demonstrate our values.
• Provide overall direction, activities and function as the authority and expert on chemistry and microbiology strategy, procedures and techniques, and regulatory compliance.
• Active leader and decision-maker on internal projects related to formulation, filling, environmental monitoring, facility improvements and developing anew approach to business.
• Strong leadership skills, the ability to prioritize, multitask multiple projects, and work efficiently in a dynamic manufacturing environment.
• Support data integrity through data review, investigations, and close collaboration with site Data Integrity Steward.
• Perform administrative duties associated with managing a department and staff. (i.e. establish group goals, and reviews).
• Strong mentoring skills and a track record of developing others.
• Identify quality issues, and in conjunction with QA Managers, recommend and implement corrective and preventative actions.
• Strong organizational skills.
• Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.
• Knowledge of laboratory equipment, test methods, validation documentation along with facilities, utilities, and manufacturing processes for an aseptic facility.
• Working knowledge of lean/six sigma methodologies and proven record of process improvement.
• Knowledge of agency and vendor audits.
• Strategic and strong communication skills with the ability to present complex data to diverse audiences.
• Ability to evaluate current systems and processes to determine upgrades, additional technology and improve as needed.
• Write, review and /or approve departmental documents, SOPs, reports and investigations.
• Support document approval for URS, DQ, Protocol (IQ, OQ, PQ) Validation, Change request, Risk Assessments, Reports, OOS Test plans/ Transfers, laboratory documents/ Testing and SOPs related to the department functions.
• Work with manufacturing and laboratory staff in managing investigations, deviations and CAPAs.

Department Specific / Non-Essential Functions:

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
• Enforce EHS procedures and respond to EHS concerns within area of operational responsibility. Perform incident investigations and follow through regarding corrective actions.
• Other duties as assigned with or without accommodation.

Qualifications:

• Thorough knowledge of cGMPs, GLPs, and pharmaceutical manufacturing requirements. Demonstrated auditing and corrective action proficiency.
• Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.
• Demonstrated proficiency in root cause analysis as applied in a pharmaceutical manufacturing environment. Excellent problem solving and decision-making skills.
• Ability to manage and drive change.
• Six Sigma Greenbelt certification.
• Supervisory skills.
• Computer skills.
• Knowledge of document management/quality systems.
• Ability to manage projects with multiple functional groups without direct reporting authority.
• Strong communication and interpersonal skills.
• Getting work done through others that are not direct reports.
• Operates with minimal direction, self-starter.
• Building relationships with other departments.
• Presentation skills.
• Statistical Analysis capability.
• BA/BS in chemistry, biology, microbiology and/or life sciences.
• Minimum 8 years pharmaceutical experience/laboratory management and/or related pharmaceutical experience.
• Previous management level experience.

Organizational Relationships / Scope:

• This position reports to the Site Quality Manager.
• May provide coverage for Site Quality Manager in his/her absence.
• Interacts with corporate regulatory affairs personnel and external Regulatory inspectors (FDA/IMB/GCC).

Working Conditions:

• Work performed in office conditions at a manufacturing facility, with expectations that time is spent in the laboratories and manufacturing environment.
• Minimal laboratory work to facilitate customer complaint investigations.

Published Category: Quality & Validation