Sr. Manager - Quality Control - United States
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- We have an immediate opening for a Sr. Manager - Quality Control to lead our QC Analytical, Microbiology, and Inspection teams.
- This position is responsible for the day to day management and strategic planning of Quality Control laboratories of NNUSBPI.
- Areas of responsibility may include Analytical Chemistry Testing, Bio-Analytical Testing, Microbiology support (including oversight of product testing and environmental monitoring programs) and inspection functions that may include packaging, returned goods inspection and raw material inspection.
- Job responsibilities also include maintenance of a high level of compliance with cGMP’s and other relevant regulatory requirements.
- This position interacts with internal customers that include staff representing Manufacturing, MSAT, Facilities & EH&S, Quality Assurance and Materials and Procurement etc.
Reports to Director, Quality Control & Quality Assurance
Main Job Tasks:
- Provides guidance to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees. Recommends changes to unit or sub-unit policies.
- Works on problems of moderate to complex scope, where analysis of situation or data requires review of identifiable factors.
- Exercises judgment within defined procedures and policies to determine appropriate action.
- Acts as advisor to unit or sub-units and becomes actively involved as required to meet schedules or resolve problems.
- Interaction: Frequently interacts with employees, customers, and functional peer groups at various management levels.
- Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.Supervision: Provides immediate supervision or assigns tasks to a unit or group of employees.
- Responsible for the reviews of direct reports with the input from senior management.
- May provide general or direct supervision to exempt employees and/or skilled nonexempt employees.
- A portion of the time may be spent performing individual tasks.Duties include but are not limited to:Reviews assay data for accuracy as well as compliance to specifications and reports abnormalities such as statistically relevant trends.Prepares certificates of analysis for intermediates and products
- Reviews trending data and writes reports summarizing the trendsSchedules laboratory work in support of commercial, clinical and/or pre-clinical programs as needed.Supervises laboratory activities in areas of analytical chemistry and biochemistry testing, bio-analytical testing, microbiology and inspection.Investigates and resolves issues related assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
- Also supervises OOS investigations Oversees CAPA-related activities in areas under management.Oversee routine and specialized assays in standard techniques.Oversee maintenance, calibration, and troubleshooting of equipment.Oversees laboratory-related computer systems.
- Responsible for initiation of document reviews, periodic reviews and documentation revisions as needed.Provide oversight, guidance and timely and accurate closure for CCAs, CAPAs, deviations, investigations and audit findings.Oversee warehouse and inspection activities from a Quality perspective, includes inspection of raw materials, intermediates, final product, and packages finished goods.
- Support activities in other departments as requested.Other duties as assigned.Assures all activities comply with established company policies and perform all duties in compliance with global regulatory requirements, the NNUSBPI Quality Manual and SOPs.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes. Incorporates the company Way and 10 Essentials in all activities and interactions with others.
Travel: 0 - 10%, inside and outside of the US. Must be able to acquire all required documentation for local and international travel
Development of People:
- Ensure that reporting personnel have 3P forms with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
- Manage the application and communication of all company policies, procedures, and company Way.
- Ensure that the IDP forms include completed Learning and Aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility.
Knowledge, Skills and Experience:
- Bachelor’s degree or Master’s degree or equivalent experience in Biology, Biochemistry, Chemistry or related field.
- Bachelor’s degree (or equivalent) in a scientific discipline and 10+ years of QC experience in a pharmaceutical or biotechnology company and six (6) years of supervisory experience Exceptional communication skills and the proven ability to integrate into a team and manage complex projects.
- Strong planning and organizational skills, and flexibility to change work priorities as necessary.
- A minimum of five (5) years’ experience in a licensed drug, device, or biologic facility regulated by FDA, EMEA or a leading international agency in a quality role.
- Must have practical experience in working with the U.S. and international requirements for biological and/or pharmaceuticals.