Director of Quality Assurance

3 weeks ago

Frederick, United States Valogic Bio Llc Full time

**Company Overview**:
**For more than 20 years VaLogic has been a reliable and trusted partner for GxP compliance. We offer a wide range of services. Our specialization in pharmaceuticals, biotechnology and life science ensures that we guarantee unwavering compliance, operational efficiency, and excellence. Our mission, “To support those on the quest for the cure.”**:
**Job Title: Director of Quality Assurance**

**FLSA Status: Salaried/Exempted**

**Job purpose**

**Duties and Responsibilities**

Below are the primary job duties and responsibilities. This is not an exhaustive list of responsibilities:

- Overall responsible for the management of the Quality Management System, including and not limited to, CAPA, change control, investigations, complaints, audits, all issues cGMP and regulatory
- Ensure SOP’s (Standard Operating Procedures) are in compliance with GxP, ISO and pertinent regulatory bodies
- Communicates with all service departments, and leadership regarding Quality Assurance
- Approve and review reports, methods, validations and protocols in all service lines, safety and regulatory functions as necessary
- Manage Change Control
- Write and review SOP’s
- Directs and coordinates the activities of QA employees
- Oversees routine internal audits of quality management systems
- Assist and manage audits conducted by regulatory agencies, clients, and consultants
- Perform supplier quality audits as needed
- Assist in writing and preparing responses to the audit findings by clients and regulatory agencies
- Communicate compliance issues to the leadership as they arise.
- Review and approve standard operating procedures, instrument calibration/validation/qualification protocols and reports, validation protocols and reports, study protocols and reports, investigations, extensions, and Corrective and Preventive Actions (CAPA).
- Manage investigations (non-conformance, deviations, Out of Specifications) program. Ensure timely completion of investigations.
- Ensure adequacy of investigations with respect to root cause/s analysis, and CAPA assessment.
- Conduct and document training on SOPs, and cGMP topics as deemed necessary.
- ** Qualifications and Skills**
- ** Education and Experience**
- Professional degree (BA, BS, MS) in a biotech
- or pharmaceutical-relevant major such as Microbiology, Biology, Biochemistry, Chemistry, or Engineering.
- At least 7-10 years of relevant industrial experience with increasing levels of responsibility in areas such as drug development and clinical manufacturing, Validation, Quality Control, Quality Assurance, and Manufacturing. Demonstrated expertise with cGMP requirements and current industry practices are required.
- Understanding of global regulations, FDA Guidance for Industry. Points to Consider, ICH Guidelines and Industry Best Practices
- **Skills and Abilities**
- Excellent organizational, interpersonal skills, and communication (written and verbal) skills.
- Demonstrated leadership skills, able to lead a team as well as work productively as an individual contributor.
- The ability to exercise independent administrative judgment.
- The ability to handle diverse tasks in an active office.
- Working knowledge and experience in MS Word, MS Excel, MS PowerPoint preferred.
- **Direct reports**
- Responsible for all employment processes, development and performance of departmental staff
- ** Conclusion**

This job description is intended to convey information essential to understanding the scope of the job and the general nature and level of work performed by job holders within this job. But this job description is not intended to be an exhaustive list of qualifications, skills, efforts, duties, responsibilities or working conditions associated with the position.

**EEO Statement**:
VaLogic Bio, LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

  • Director, Quality Assurance

    4 weeks ago

    Frederick, United States Precisionscientia Full time

    Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to...

  • Quality Assurance Specialist IV

    3 weeks ago

    Frederick, United States Frederick National Laboratory for Cancer Research Full time

    Quality Assurance Specialist IV Job ID: req3953Employee Type: exempt full-timeDivision: Vaccine, Immunity and CancerFacility: Frederick: ATRFLocation: 8560 Progress Dr, Frederick, MD 21701 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...

  • Quality Assurance Specialist IV

    3 weeks ago

    Frederick, United States Frederick National Laboratory for Cancer Research Full time

    Quality Assurance Specialist IV Job ID: req3953Employee Type: exempt full-timeDivision: Vaccine, Immunity and CancerFacility: Frederick: ATRFLocation: 8560 Progress Dr, Frederick, MD 21701 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by...

  • Quality Assurance Specialist IV

    4 days ago

    Frederick, Maryland, United States Frederick National Laboratory for Cancer Research Full time

    Quality Assurance Specialist IVJob ID: req3953Employee Type: exempt full-timeDivision: Vaccine, Immunity and CancerFacility: Frederick: ATRFLocation: 8560 Progress Dr, Frederick, MD 21701 USAThe Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos...

  • Head of Quality Assurance

    2 weeks ago

    Frederick, United States Competence Skills Pvt Ltd Full time

    **Job Title: Head of Quality Assurance** ** direct hire** **Job Location: Frederick, MD (Onsite)** Are you looking for a challenging role that allows you to contribute to innovation and bring high-quality affordable medicines to patients? If so, A head of Quality role (Director Level) could be an ideal opportunity for you. As a Head of quality, you will...

  • Head of Quality Assurance

    6 days ago

    Frederick, United States Competence Skills Pvt Ltd Full time

    Job Title: Head of Quality Assurance Job Type: Full-time direct hire Job Location: Frederick, MD (Onsite) Are you looking for a challenging role that allows you to contribute to innovation and bring high-quality affordable medicines to patients? If so, A head of Quality role (Director Level) could be an ideal opportunity for you. As a Head of quality, you...

  • Quality Assurance Specialist

    4 days ago

    Frederick, Maryland, United States Chimera Enterprises International Full time

    . Chimera Enterprises International is seeking a Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND) JPEO-CBRND Medical Office. The JPEO-CBRND manages our nations investments in chemical, biological, radiological, and nuclear defense equipment, and medical...

  • Quality Assurance Specialist

    2 months ago

    Frederick, United States Chimera Enterprises International Full time

    Job DescriptionJob DescriptionDescription. Chimera Enterprises International is seeking a Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND) JPEO-CBRND Medical Office.  The JPEO-CBRND manages our nation’s investments in chemical, biological, radiological, and...

  • Quality Assurance Specialist

    3 weeks ago

    Frederick, United States Chimera Enterprises International Full time

    Job DescriptionJob DescriptionDescription. Chimera Enterprises International is seeking a Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND) JPEO-CBRND Medical Office.  The JPEO-CBRND manages our nation’s investments in chemical, biological, radiological, and...

  • Quality Assurance Specialist Iii

    3 hours ago

    Frederick, United States Kite Pharma Full time

    At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and...

  • Quality Assurance Specialist

    4 weeks ago

    Frederick, United States QED Systems LLC Full time

    Job DescriptionJob DescriptionQED Systems, LLC, is currently recruiting a Quality Assurance Specialist to join our team at Fort Detrick, MD to support Project Manager Tactical Network (PM TN). This role will be primarily responsible for providing support to the Global Agile Integrated Transport (GAIT) Network Support Center (NSC). This position is contingent...

  • Quality Assurance Specialist

    3 weeks ago

    Frederick, United States QED Systems LLC Full time

    Job DescriptionJob DescriptionQED Systems, LLC, is currently recruiting a Quality Assurance Specialist to join our team at Fort Detrick, MD to support Project Manager Tactical Network (PM TN). This role will be primarily responsible for providing support to the Global Agile Integrated Transport (GAIT) Network Support Center (NSC). This position is contingent...

  • Quality Assurance Specialist Ii

    3 weeks ago

    Frederick, United States AstraZeneca Full time

    Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to...

  • Quality Assurance Specialist II

    4 days ago

    Frederick, Maryland, United States Precisionscientia Full time

    Position Summary:The Quality Assurance Specialist II will provide intermediate-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process...

  • Quality Assurance Specialist Iii/iv

    2 weeks ago

    Frederick, United States AstraZeneca Full time

    Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to...

  • Senior Scientist, Associate Director, Quality Control

    2 months ago

    Frederick, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryCartesian Therapeutics is seeking a Senior Scientist/Associate Director, QC for the company's New Horizon facility. You will oversee QC analytical testing laboratories, including in-process testing and lot release QC testing. The Senior Scientist/Associate Director, QC will have both quality control and method...

  • Senior Scientist, Associate Director, Quality Control

    3 weeks ago

    Frederick, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryCartesian Therapeutics is seeking a Senior Scientist/Associate Director, QC for the company's New Horizon facility. You will oversee QC analytical testing laboratories, including in-process testing and lot release QC testing. The Senior Scientist/Associate Director, QC will have both quality control and method...

  • Senior Scientist, Associate Director, Quality Control

    2 weeks ago

    Frederick, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryCartesian Therapeutics is seeking a Senior Scientist/Associate Director, QC for the company's New Horizon facility. You will oversee QC analytical testing laboratories, including in-process testing and lot release QC testing. The Senior Scientist/Associate Director, QC will have both quality control and method...

  • Senior Scientist, Associate Director, Quality Control

    3 weeks ago

    Frederick, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryCartesian Therapeutics is seeking a Senior Scientist/Associate Director, QC for the company's New Horizon facility. You will oversee QC analytical testing laboratories, including in-process testing and lot release QC testing. The Senior Scientist/Associate Director, QC will have both quality control and method...

  • Sr. Biodefense Regulated Quality Review Specialist

    4 weeks ago

    Frederick, United States Alakaina Family of Companies Full time

    The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Senior Biodefense Regulated Quality Review Specialist to support our contract with USAMRIID in Frederick, Maryland. The candidate shall provide Quality Review (QR) Specialist support, to include 100% reviews of data, spreadsheets, tables, listings, figures, etc., as well as SEND...