Associate Director/Director, External QC

3 weeks ago


Oklahoma City, United States HireMinds Full time

Our clinical stage pharmaceutical company is growing and looking to add an

Associate Director/Director, External QC Microbiology (REMOTE)

to their team This role will provide oversight of all external cGMP Microbiology, Environmental Monitoring, Virology testing. They will work in partnership with Technical Operations, Quality Assurance and external laboratories to assure that QC Microbiology, Environmental Monitoring, and Virology testing are performed in compliance with applicable regulations, company quality standards, and current industry practices. The responsibilities also include providing leadership for all microbiological aspects relevant to manufacturing, identifying and mitigating product quality, safety, and regulatory compliance risks, as well as working to establish internal Quality Control processes and procedures.

Oversees the overall Quality Control Microbiology and Virology release testing strategy

Ensures the Environmental Monitoring program at external manufacturing sites meet applicable regulatory requirements

Ensures proper investigation into the root cause of product and/or process failures

Leads OOS investigations, deviations, CAPA and change controls

Provides support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods

Drafts and reviews appropriate sections of Regulatory submissions

Interacts with agents from Regulatory agencies and participates in Audits and Inspections

Supports the preparation of dossiers and data packages for interactions between Company’s and Regulatory agencies

Writes and proposes revisions to Standard Operating Procedures, Analytical Methods, Technical Reports, and related Forms.

Reviews and assesses proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate

Liaises with other departments to ensure business continuity including Quality, Manufacturing, MS&T, Supply Chain, and Regulatory

Requirements:

Minimum of a bachelor’s degree in biological sciences; advanced degree in biological sciences desirable

A minimum of 8 years’ experience in a QC microbiology testing laboratory

A minimum of 4 years’ experience in a management role

Experience with coordinating QC testing at external contract laboratories

Experience with aseptic manufacturing and biologics/vaccines

Expertise in microbiology, virology and environmental monitoring testing

Strong understanding of Quality Control testing requirements for pre-clinical, clinical, and commercial stage work.

Comprehensive knowledge of compliance with cGMP regulations

Highly skilled in root cause investigations, change control, and regulatory inspections

Able to handle multiple projects and exercise good judgment in prioritizing tasks

Excellent verbal, written and organization skills

Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)

Other:

Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.

Some international travel may be required.

Location Remote-US East Coast preferred

#J-18808-Ljbffr



  • Oklahoma City, United States HireMinds Full time

    Our clinical stage pharmaceutical client HQ in Boston, MA is growing and looking to add an Associate Director/Director of External QC (Analytical) (REMOTE). This role will provide oversight of all external cGMP analytical testing. They will work in partnership with Technical Operations, Quality Assurance and external laboratories to assure that QC analytical...


  • Oklahoma City, United States Longevitylist Full time

    Associate Director/Director, Quality Control At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing. POSITION SUMMARY The Director of Quality Control will be leading the Quality Control Unit at eGenesis designing and establishing the analytical operations...


  • Oklahoma City, United States Kemioconsulting Full time

    KEMIO are representing a global pharmaceutical company in Cambridge, MA, who are building their cheminformatics capabilities at the R&D site. 29th May, 2024 Associate Director or Director, Cheminformatics Cambridge, Massachusetts 29th May, 2024 Associate Director or Director, Cheminformatics Cambridge, Massachusetts Generative AI, Drug Discovery,...


  • Oklahoma City, United States Morphic Therapeutic Full time

    Description About Morphic Therapeutic Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...


  • Oklahoma City, United States Cardurion Pharmaceuticals Full time

    Description Why join Cardurion Pharma? At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive...


  • Oklahoma City, United States CenterWell Full time

    Description The Associate Medical Director serves as a health-care professional and capable of handling a variety of health-related problems. The Associate Medical Director requires a solid understanding of how organization capabilities interrelate across department(s). Responsibilities The Associate Medical Director has similar job duties as a Physician,...


  • Oklahoma City, United States Nimbus Therapeutics Full time

    Associate Director, Biology (Immunology) Nimbus has an outstanding opportunity for an exceptional Associate Director of Biology to join our team. The person in this role will take on a variety of responsibilities contributing to Nimbus’ current, ongoing projects and strategy, as well as evaluation of potential new targets. This role will primarily support...


  • Oklahoma City, United States Tome Full time

    Reporting to our Senior Director, Drug Product, Process Development, we are seeking an Associate Director to join our team. This position is predominantly a lab-based role and will be responsible for developing scalable processes for LNP delivery of gene-editing RNA cargos. This position will play a critical role in successfully developing manufacturing...


  • Redwood City, United States Codexis, Inc. Full time

    Department 64 - QC & Analytical Development Employment Type Full Time Location Redwood City, CA Workplace type Onsite DescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director of Quality Control. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology...


  • Redwood City, United States Codexis Full time

    Department 64 - QC & Analytical Development Employment Type Full Time Location Redwood City, CA Workplace type Onsite Description Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director of Quality Control. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver®...


  • Redwood City, California, United States Codexis, Inc. Full time

    Department64 - QC & Analytical DevelopmentEmployment TypeFull TimeLocationRedwood City, CAWorkplace typeOnsiteDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director of Quality Control.Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover,...


  • Oklahoma City, United States Okcu Full time

    VP Area: Enrollment Services Department: Admissions FLSA Status: Exempt Benefit Eligibility: Yes Position Summary: The associate director is responsible for performing a wide variety of admissions and recruitment duties in support of the Admissions department's efforts to significantly increase and sustain the university's student population through...


  • Oklahoma City, United States Affini-T Therapeutics Inc. Full time

    About Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application...


  • Oklahoma City, United States Pacific Clinics Full time

    Pacific Clinics is California's largest community-based nonprofit provider of behavioral and mental health services and support. Our team of more than 2,000 employees speak 22 languages and are dedicated to offering hope and unlocking the full potential of individuals and families through culturally responsive, trauma-informed, research-based services for...

  • Director of Operations

    2 months ago


    Oklahoma City, United States OnPoint Surgical, Inc. Full time

    The Director of Operations (DO) is responsible for setting the operational strategy to meet manufacturing and fulfillment demands at OnPoint Surgical, Inc. This is the opportunity for a strategic and hands-on leader to own Production operations in a dynamic, entrepreneurial environment. You will be responsible for the setup and expansion of the manufacturing...


  • Oklahoma City, United States HireMinds Full time

    Our clinical stage vaccine client here in Boston, MA is growing and looking to add a Director, QA Operations (REMOTE) to their team! This role will be responsible for oversight of GMP activities and disposition of clinical supplies. They will be responsible for working in partnership with Technical Operations, and GMP suppliers to assure compliance with...


  • Oklahoma City, United States HireMinds Full time

    Our clinical stage pharmaceutical client here in Boston, MA is growing and looking to add an Associate Director, Product Quality Leadership (REMOTE) to their team! This role will provide oversight of GMP product quality and work in partnership with Technical Operations, Quality Control, Regulatory Affairs, and GMP suppliers to assure compliance with quality...


  • Oklahoma City, United States WittKieffer Full time

    Associate Director of High School and Family Ministry Description YOU MUST COMPLETE ALL FIELDS ON THIS APPLICATION TO BE CONSIDERED FOR THIS POSITION. Remember to include your cover letter. The Associate Director of High School and Family Ministry is a key leadership role responsible for fostering the spiritual development, engagement, and support of high...


  • Oklahoma City, United States OU Health Full time

    Position Title: Director - Neonatal Advanced Practice Department: Advance Practice Providers Job Description: General Description: Director, Neonatal Intensive Care Unit (NICU) Advanced Practice (NP/PA) Purpose of Role: The Director, Neonatal Intensive Care Unit (NICU) Advanced Practice is responsible for directing, coordinating, and managing the health care...


  • Oklahoma City, United States AstraZeneca plc Full time

    **Global Biotransformation Leader (Associate Director / Director ~ DMPK Oncology R&D)** **Permanent Opportunity** **Location: Cambridge, UK / Waltham, US** **ABOUT ASTRAZENECA** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of...