Senior Specialist, QA Auditing

Description

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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Specialist, QA Auditing leads and conducts internal audits to assess the quality / compliance of current Good Manufacturing Practice (cGMP), applicable regulations, and applicable company policies and procedures. The incumbent may support or lead small scale 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. This role ensures corrective measures are implemented, provides transparency of risks from non-compliance, and 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.

Duties & Responsibilities

• Schedules, plans, and prepares for internal audits of Operations, Development, Biopharma and Animal Health facilities for BIVI and other BI operating units, and external audits of suppliers and contractors for BIVI and other BI operating units.

• Leads and conducts internal audits of Operations, Development, Biopharma and Animal Health facilities for BIVI and other BI operating units.

• May support or lead small scale external audits of suppliers and contractors.

• Prioritizes and self-manages audit and inspection tasks.

• Creates and issues audit report for each audit to submit to BIVI management 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 contract manufacturers, laboratories, and suppliers.

• Performs follow-up actions, including over-site of compliance issues noted during audits and inspections or otherwise observed or reported.

• Plans, performs, documents, and conducts required post-audit activities for assigned internal and external audits to ensure timely closure of CAPAs.

• Communicates deviations from the cGMP or other Regulations observed during audits/inspections, recommends appropriate corrective action when necessary, and verifies that appropriate corrective actions have been implemented that adequately address any deviations reported during audits to BI Quality Management.

• Resolves 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.

• Develops, reviews and/or approves documents associated with Supplier Quality Management (e.g., change controls, specifications, compliance certificates, etc.).

• Enables global quality overview of BI suppliers, challenges their status and identifies gaps/risks for BI's Supply Chain Integrity.

• Acts as a resource for colleagues on regulatory matters (particularly USA and EU) regarding Good Manufacturing Practice (GMP) for APIs, excipients and Good Distribution Practice, and pharmaceutical products (GDP).

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 guidance 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 judgement 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.