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Senior Manager, Regulatory

Job Attributes

Job Id:

20018

Job Category:

Clinical & Life Sciences

Job Location:

Frederick, MD  21703

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Life Sciences is currently looking for a Senior Manager, Regulatory in Frederick, MD to work for a cutting-edge biotechnology company developing and delivering innovative technologies for the prevention of infectious diseases.

 

Responsibilities for the Senior Manager, Regulatory Include:

  • Develops the internal audit schedule, taking into account potential compliance risks.
  • Oversees internal audits, ensuring that the audit team has the appropriate knowledge, education and experience to be able to identify significant issues through coaching and educational opportunities.
  • Works with site leadership to identify and implement remediation in a timely manner.
  • Communicates the compliance status of the site to management.
  • Oversees the vendor qualification program:
  • Provides guidance to the vendor audit team, ensuring that the qualification program meets current regulatory expectations.
  • Works with PP&L to implement systems to ensure that only qualified suppliers are utilized for those materials and services that require the use of qualified suppliers.
  • Through coaching and education, ensures that auditors have the appropriate knowledge, education and experience to perform effectively.
  • Works with customers to schedule audits, ensuring that requirements defined in Quality agreements are upheld.
  • Responsible for supporting execution of and response to customer audits.
  • Works with site leadership to identify and implement remediation in a timely manner.
  • Ensures appropriate communication with customers before, during and after audits.
  • Ensures readiness for routine GMP inspections and pre-approval inspections through an effective internal audit program.
  • Ensures readiness for pre-approval inspections through close coordination with customers and internal project teams.
  • Provides inspection readiness
  • Manages inspection logistics and communications to the site, corporate management and customers.
  • Hosts Regulatory inspections and authors responses to Regulatory bodies.
  • Works with site leadership to identify and implement remediation in a timely manner.

 

Qualifications for the Senior Manager, Regulatory Include:

  • BA/BS in relative scientific or technical discipline field
  • Preferred area of study:  Science or engineering, biological sciences
  • Experience in a cGMP environment and related QA field, 5-10 years; Experience in managing and hosting international regulatory inspections
  • Certified Quality Auditor preferred
  • Strong focus on continuous improvement and quality, willing to work with others in a fast-paced environment, conscious of the need to implement improvements as a team. 
  • Strong interpersonal communication, ability to write in a clear, concise
  • Experience in managing and hosting international regulatory inspections

 

Keywords:

Quality assurance, QA, QC, quality control, gcp, cgcp, gmp, cgmp, FDA, EMA, MCC, regulatory, quality management, pharmaceutical, pharma, combination device, biotechnology, regulatory, benefits, vacation, holiday, 401(k)

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Job Id:

20018

Job Category:

Clinical & Life Sciences

Job Location:

Frederick, MD  21703

Security Clearance:

No Clearance

Business Unit:

Piper Companies