Director, Microbiology Quality Assurance
hace 2 meses
Job Description**This position can be fully remote**Position Overview: (Basic Functions & Essential function(s) includes, but is not limited to:Responsible for providing leadership and direction for microbiology related topics in sterile, non-sterile, biologic manufacturing, and/or Microbiology LaboratoriesLeads the development, deployment and maintenance of multiple divisional quality guidelines or SOPs to ensure Organon is compliant to cGMPs for these topics.In collaboration with stakeholder functions within Organon Manufacturing & Supply (OMS), establishes and executes microbiological strategy to support Organon's product portfolio and manufacturing networkEstablish direct report career development in technical and leadership functionsMain Activities: (Primary activities include, but are not limited to:Leads direct reports that identify and translate regulatory requirements and cGMP expectations for Microbiology Laboratory, Sterile and Non-Sterile Operations.Maintain the Microbiology quality standards and SOPs in alignment with regulatory requirements and cGMP expectations.Ensure consistency in sites meeting the standards for the topic (e.g.
providing training, supporting gap assessments, reviewing remediation plans and variances performed by direct reports)Tracking metrics for the Organon network sites to meet the microbiological standardsProvide support to CMC when inquiries arise from regulators during review of filingsOrganize and facilitate compliance related communities of practice related to microbiological topicsRepresenting Organon in external forums, conferences, and working groups such as ISPE, PDA, and similar industry and trade associationsLead teams to assess impact of proposed and official changes and determine actions needed to maintain compliance and/or prepare correspondence with pharmacopoeia related to microbiology outlining Organon's positionsPromote process optimization efforts, application of best practices, and maintenance of tools/programs utilized to facilitate microbiological processes & compliance to evolving regulatory expectations and industry trendsProvides insight and contributes to Quality Management System programs as related to microbiological matters.Develops strategic priorities related to microbiological mattersMaintains a broad-based knowledge of cGMP's, company's Policies, procedures and guidelines, regulatory requirements, compendial requirements, etc.
pertinent to the manufacturing, personal safety, control, testing and documentation of pharmaceutical products.Skills:Degree required, concentrations in life sciences or related relevant discipline.
Minimum of 15 years' experience in the FDA and/or EU regulated pharmaceutical environment; preferably with significant work in the area of microbiologyIn-depth knowledge of end-to-end compendial processes related to m including interactions with global (e.g., USP and EP) and national (e.g., IP, ChP, JP, etc.)
pharmacopeia is desiredWorking knowledge of microbiological analytical techniques used in commercial testing of excipients, drug substance and drug products required, preferably with different product modalities (e.g., biologics and pharmaceutical products)Expert knowledge of EMEA, MHRA, and FDA regulationsExpert knowledge of Sterile Processing, Microbiology Laboratory & Testing, and/or microbiology topics for nonsterile or bioburden reduced products.Highly experience in regulatory inspection and responses.Highly experience in listening to and gathering a range of perspectives and with ability to develop solutions and champion a positionDemonstrated ability with strategy & organizational development, project management, establishing and reporting meaningful metrics is a plusAbility to lead teams, managing multiple projects/tasks simultaneously with competing prioritiesStrong collaborative and communication skillsSecondary Language(s) Job DescriptionWho We Are:Organon delivers ingenious health solutions that enable people to live their best lives.
We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.
We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman.US and PR Residents OnlyFor more information about personal rights under Equal Employment Opportunity, visit:Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.
Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience.
The applicable salary range for this position in the U.S. is stated below.
Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.Annualized Salary Range (US)Annualized Salary Range (Global)Annualized Salary Range (Canada)Please Note: Pay ranges are specific to local market and therefore vary from country to country.Employee Status: RegularRelocation:No relocationVISA Sponsorship:Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.Flexible Work Arrangements:Shift:Valid Driving License:Hazardous Material(s):Number of Openings: 1
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