Manager, QC Sterility Assurance

2 weeks ago

Wilmington, United States Planet Pharma Full time

DIRECT HIRE MUST HAVES : Bachelor’s degree in a relevant discipline (i.e. biological sciences or similar) 6+ years of experience in the pharmaceutical (or related) industry within a Quality Control microbiology role Experience with environmental monitoring, management, and oversight of a cleanroom (i.e. sterilization, aseptic processing control, auditing, etc.) Experience executing microbial method and microbial validation procedures Position Overview : The Manager, Quality Control (QC) Sterility Assurance is responsible for effectively collaborating with multiple stakeholders to ensure the harmonized execution of contamination control policies across the two manufacturing sites in Philadelphia. This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods. The Manager, QC Sterility Assurance will have strong leadership and substantial experience leading QC sterility assurance program in a Pharmaceutical or Biotechnology environment. The QC Sterility Assurance Manager is a key support role. Essential Functions and Responsibilities : Championing sterility assurance principals at the site in the areas of aseptic processing, and contamination control. Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments. Assist with the design of the contamination control strategy. Develop and maintain the microbial contamination/Cross contamination risk assessment (HACCP). Develop and maintain the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance and technical soundness. Develop EM and Utility trending reports within deadlines, for the 2 sites in PA. Supports the APV strategy. Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls. Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs). Assist with relevant internal and external inspection responses/action items related to contamination control issues. Establishes and implements appropriate training programs in collaboration with training leads. Ensure alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites. Plays a critical role in facility design and modification, cleaning and sanitization program, operator qualification, gowning certification, manufacturing support, training, investigations, inspections, and audits. Participates as microbiology SME in inspections. Troubleshoots contamination related issues occurring in internal and external manufacturing sites. Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records. Owns change control tasks associated with qualification or program revisions. Regular communication to senior levels of management for issues related to contamination control. Champions new initiatives and acts as the catalyst for microbiology related changes within QC and potentially across divisions. Reviews and provides oversight for microbial testing performed at contract laboratories. Participates in continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance. Performs regular GEMBA style assessments of the aseptic process on site to assess compliance of operations including identification of deficiencies and provide real time coaching to aseptic staff. Perform routine audits of the manufacturing areas. Authors new and revised procedures for Sterility Assurance department. Ability to work in a team environment and independently as required. Maybe required to work Holidays and weekends. Ability to evaluate technical data and write technical documents. Advanced data integrity knowledge and practices. Intermediate understanding of statistics, control charts, action, and alert limits. Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc. Required Education, Skills, and Knowledge : Bachelor’s degree in a relevant discipline (biological sciences or equivalent). Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role. Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Knowledge and familiarity with Annex 1. Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin, mycoplasma testing, and microbiological control strategy required. Broad knowledge of quality control for biologics with experience in microbial contamination control. Experience with microbiological risk assessments. Successfully interface with multi-disciplined teams Extremely detail-oriented with strong analytical, written, and verbal communication skills Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. High level of ownership and accountability Demonstrate sense of urgency; ability to recognize time sensitivity. Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders. Flexible and adaptable style with an eagerness to take on challenges. Problem solver who not only identifies issues but leads efforts to resolve them. Excellent oral and written communication skills with strong technical writing experience required. Preferred Education, Skills, and Knowledge : Advanced degree preferred. Experience with cell therapy products is a plus.

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