Senior / Principal Specialist, QA Auditing

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 30 days ago

Description:

Leads and conducts external audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and applicable company policies and procedures of external suppliers and contractors on behalf of the BIV-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Ensures corrective measures are implemented. Provides transparency of risks from non-compliance. Assesses the implementation and execution of quality / GMP standards at suppliers and contractors to meet FDA/EU and other relevant regulatory requirements, and to prevent and mitigate quality risks. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

This position may work onsite at one of the U.S. BI sites, or have the possibility of remote work.

Duties & Responsibilities

  • Schedule, plan, and prepare for external supplier and contractor audits on behalf of BI pharmaceutical world functions, including Operations, Development, Biopharma and Animal Health, as well as internal audits of BIVI and other BI operating units Operations, Development, Biopharma and Animal Health divisions.
  • Lead and conduct audits of external suppliers and contractors on behalf of the BIV-US facilities and external suppliers and contractors on behalf of the BI manufacturing world, including Operations, Development, Biopharma, and Animal Health. Prioritize and self-manage audit and inspection tasks.
  • Create and issue the audit report for each audit to submit to BIVI management as a means to ensure SOP(s), facilities, systems, processes and studies conform to applicable cGMP, Good Laboratory Practices (FDA, USDA, EU), Good Clinical Practices (FDA), and/or Guidance Documents (FDA, USDA, EU) internally and for external
  • Perform follow-up actions and oversee investigations of compliance issues noted during audits and inspections or otherwise observed or reported.
  • Perform follow-up actions, including over-site of compliance issues noted during audits and inspections or otherwise observed or reported. Plan, perform, document, and conduct required post-audit activities for assigned internal and external audits to ensure timely closure of CAPAs. Communicate deviations from the cGMP or other Regulations observed during audits/inspections, recommend appropriate corrective action when necessary, and verify that appropriate corrective actions have been implemented that adequately address any deviations reported during audits to BI Quality Management.
  • Resolve quality concerns and implement quality improvements by meeting with other department Managers, Staff Managers to assure current methods, procedures or SOP’s meet current standards. Develop, review and/or approve documents associated with Supplier Quality Management (e.g., change controls, specifications, compliance certificates, etc.).
  • Mentor and train other BI auditors regarding auditing skills and current and future quality and regulatory trends as part of BI global supplier auditor training. Serve as the subject matter expert to suppliers on compliance topics for BIVI. Acts as a resource for colleagues (especially USA and EU) regarding Good Manufacturing Practice (GMP) for APIs, excipients and Good Distribution Practice, and pharmaceutical products (GDP).
  • Enable global quality overview of BI suppliers, challenge their status and identify gaps/risks for BI's Supply Chain Integrity.

Principal Specialist Requirements:

  • Requires a Bachelor's Degree in Industrial Engineering, Biology, Chemistry or other related degree.
  • Requires a minimum of eight (8) years progressive experience in comparable quality or auditing function in a GMP regulated environment.
  • Requires a Quality Engineer / Auditor certification from ASQ or equivalent and qualification as a Lead Auditor.
  • One (1) to three (3) years project management experience
  • Advanced/in-depth knowledge of relevant regulations and guidances as well as understanding of scientific methods and processes used to manufacture, test, evaluate and distribute biological and pharmaceutical products;
  • In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series) and cGMP regulations and related practices required
  • Willing and able to travel at least 70% of the time.
  • Works independently with minimal guidance.
  • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed. Strong independent judgment and decision making abilities required.
  • Excellent analytical skills.
  • Excellent conflict resolution and negotiation skills
  • Excellent verbal and written communication skills and the ability to conduct respectful interactions with individuals with diverse views or backgrounds
  • Ability for work in cross-functional teams and with international alignment.
  • Knowledge of process improvement concepts and applications in compliance environment.
  • Required the capability to work with international business partners with intercultural sensitivity.
  • Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook).
  • Ability for work in cross-functional teams and with international alignment.

Senior Specialist Requirements:

  • Requires a Bachelor's Degree in relevant field of position.
  • Requires a minimum of three (3) years’ experience in quality or auditing in a GMP regulated environment.
  • A Quality Engineer / Auditor certification from ASQ or equivalent preferred. Qualification as a Lead Auditor preferred.
  • In-depth knowledge of relevant regulations and guidances required.
  • In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series).
  • In-depth knowledge of cGMP.
  • Willing and able to travel at least 70% of the time.
  • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed. Strong independent judgment and decision making abilities required.
  • Excellent analytical skills.
  • Must possess excellent verbal and written communication skills
  • Excellent conflict resolution and negotiation skills.
  • Knowledge of process improvement concepts and applications in compliance environment.
  • Respectful interactions with individuals with diverse views or backgrounds.
  • Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook).

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required)
  • Must be 18 years of age or older

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