Senior Specialist / Manager, GMP Quality Assurance Operations

Perform a variety of Quality Assurance operations activities to support commercial drug products, and ensure compliance with applicable US/EU/Canada regulatory requirements and Heron procedures.  Responsible for review of executed batch records and final lot disposition ensuring product lots meet specifications.  Providing Quality Assurance and compliance oversight to GMP contract service providers for manufacturing and analytical testing operations for APIs, excipients, and sterile injectables.  Closely collaborates with the cross-functional representatives on Heron Product Teams to ensure overall compliance of drug products and on-going assessment of service providers.   Responsibilities include identification and evaluation of compliance issues, providing recommendations, and leading compliant resolution of issues.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Review executed batch records and QC release data to determine final lot disposition decision by evaluating accuracy and completeness of lot file documents to facilitate timely batch dispositions.
  • Manage interactions with GMP contract service providers and provide GMP guidance and support to Heron Therapeutics Manufacturing, Quality Control, and other departments to resolve quality issues independently.
  • Identify product and compliance issues, propose solutions, and collaborate cross-functionally on resolution.
  • Lead, review, and approve deviations, investigations, CAPAs, and change records, including providing QA guidance on investigation, CAPA, and change plans.
  • Manage GMP QA SOPs, including facilitate periodic review, recommend enhancements, and ensure alignment across GMP QA.
  • Proactively evaluate systems and processes to identify improvements with a focus to simplify and standardize processes. Lead improvement initiatives and present to management as needed.
  • Review and approve master batch records, labels, and other production documents, as needed, for compliance ensuring product quality standards are met, and compliant to Heron procedures.
  • Maintain and evaluate quality metrics. Generate reports as applicable to support management and functional reviews.
  • Provides assistance in PAI and other inspection Assist in compliance audits as required.
  • Review data for and/or sections of regulatory submissions.
  • Participate in intradepartmental and interdepartmental project teams as required.
  • Maintenance of electronic records and paper archives (lot records, reports, quality events, ).

 

REQUIREMENTS:

  • Bachelor’s degree in the sciences (biology, chemistry, biochemistry, or chemical engineering) with a minimum of 5+ years of pharmaceutical experience in a GMP environment.
  • Proven understanding of Quality principles, industry practices, and standards (21 CFR, ISO, GxP, ICH, etc.) with demonstrated ability to apply these to GxP operations internally and contract service providers.
  • Experience with commercial drug product operations including injectable parenterals, finished goods production, API and excipient manufacturing, and analytical testing. Experience with polymers is ideal, but not required.
  • Independent decision making with a high degree of initiative.
  • Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
  • Innovative thinker with demonstrated ability to reconcile more complex issues independently.
  • A strong work ethic and high level of accountability and integrity.
  • Well organized and efficient with ability to manage multiple priorities.
  • Experience with QA oversight of contract service providers is desired.

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.

To apply for this job please visit www.herontx.com.

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