Experience Inc. Jobs

manager, quality systems and regulatory compliance.

• san antonio , texas

• posted may 10, 2024

job details

summary

• $100,000 - $125,000 per year

• permanent

• bachelor degree

• category computer and mathematical occupations

• reference1051838

job details

job summary:

This position is responsible for the improvement, design, development, implementation and maintenance of the GxP Quality Management System (QMS) processes as relevant to cGMP Biomanufacturing. In addition, this position will also serve as an internal Regulatory resource to ensure that appropriate processes adhere to pertinent regulations and standards. This position has a focus on activities related to Biomanufacturing and provides leadership and support to the organization in the development and testing of novel advanced therapies that are pre?clinical, clinical, or commercial

location: San Antonio, Texas

job type: Permanent

salary: $100,000 - 125,000 per year

work hours: 8am to 4pm

education: Bachelors

responsibilities:

Ensure Quality System implementation aligns with requirements of applicable regulatory and standard bodies. Lead risk assessments for introduction of new processes or changes to existing process. Ensure investigations are executed and written following a risk?based approach and follow appropriate escalation. Assess the phase appropriateness of activities pursuant to execution of client deliverables such as manufacturing and testing. Work with operations to conduct gap analyses of standards and regulations such as FDA, EU, ISO, and ICH. Coordinate and prepare responses to requests for information from regulatory agencies. Develop regulatory guidance and training document for both external and internal customers, covering topics on existing and new regulatory information, industry information, and case studies. Work collaboratively with all functional areas during process and documentation development, to ensure procedures reflect compliance with applicable standards and regulations. Assess Change Controls for impact to/from relevant Regulations to maintain compliance. Perform on?going and annual review of all changes and updates in relevant regulations and standards, and perform Regulatory Surveillance of regulatory guidance documents, changes and standards update, and update

Standards databases as needed. Inform and collaborate with relevant functional process owners for impact assessment. Actively lead and/or contribute to data relevant to Compliance and Regulatory Affairs in periodic Management Review meetings. Coordinating and actively participate in Quality or Compliance related projects. Support regulatory inspections and Quality responses at company and contract organizations and Represent Regulatory Affairs as SME and process owner in a front?room or back?room capacity during all internal and third? party audits/inspections. Support the implementation of risk management?based approaches. Represent Global Quality & Compliance on cross?functional teams to complete projects, address quality issues and identify quality system improvements. Benchmark through industry associations, system vendors etc. to ensure business processes and systems are consistent with industry best practices.

Requires five or more years of job specific experience in a clinical and/or commercial biologics development or manufacturing setting with hands?on experience in quality management systems, or regulatory affairs.

Requires 3 years of progressive responsibility in leadership of teams, experience managing and overseeing assigned team members.

Experience Prefer 5 years experience in an aseptic manufacturing facility, specific to Biologics or Drugs.

qualifications:

• Experience level: Manager

• Minimum 5 years of experience

• Education: Bachelors (required)

skills:

• Regulatory Affairs / Compliance

• Biologics Manufacturing

• Quality Management systems

• LeadershipEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).Applications accepted on ongoing basis until filled.