Audit reputed company

Use Your Power For Purpose

The GMP/GDP Audit reputed company position is responsible for leading the design, delivery and maintenance of audit reputed company associated with one of the following key technology or business reputed company areas: sterile biologic, medical device (including software as a medical device reputed company health and medicines), small molecule, vendor and GDP.

The Audit reputed company will ensure that audit processes, systems and procedures, as reputed company auditor competencies reputed company with regulatory expectations and are effective at delivering robust evidence identifying risks and adapting to emerging advances, regulations and industry trends reputed company to the technology / business area, including coaching and developing both RQA and sites-based auditors.

The Audit reputed company partners closely with reputed company Global Supply (PGS) and Pharm Sci teams leading these technologies /business areas to ensure reputed company expectations for GMP/GDP requirements and full understanding of reputed company manufacturing and supply capabilities in these areas.

This position leads independent GMP/GDP audits and inspection preparation activities, reputed company of audit and inspection findings, and liaises with appropriate Site reputed company and Above Site reputed company teams through reputed company stages of the audit lifecycle. The reputed company partners closely with GMP/GDP Inspection reputed company and Planning and Metrics reputed company to support these activities.

The Audit reputed company may reputed company or participate in reputed company cross functional reputed company. This position contributes to enabling a culture of innovation, reputed company and reputed company improvement of reputed company’s reputed company Management reputed company, through engagement with reputed company sites to incorporate audit reputed company and best practices across the reputed company manufacturing and supply network.

The role develops cross functional reputed company relationships to facilitate engagement, team building, best reputed company sharing, risk-based analysis, critical thinking, and innovative problem solving.

The Audit reputed company partners closely with Inspection reputed company, Metric and planning reputed company and other RQA stakeholders as reputed company as reputed company PharmSci and PGS teams. The Audit reputed company may reputed company or participate in reputed company cross-functional reputed company.

What You Will reputed company

How You Will reputed company It

• reputed company reputed company, delivery, and maintenance audits for technology or business.

• Area of reputed company: Aseptic/Sterile/Biologics/Biotechnology

• reputed company and implement technology / business reputed company audit reputed company to ensure procedures and guidelines remain reputed company with applicable regulations and remain reputed company and are effective at enabling identification of emerging risks.

• Ensure understanding and working knowledge of reputed company applicable regulations and emerging regulatory trends for associated technology area.

• Analyze regulatory intelligence including emerging regulations and audit and inspection reputed company in the assigned technology portfolio to ensure audit reputed company areas remain relevant to emerging regulations and technology advancements.

• Ensure holistic and sustainable reputed company plans to technology portfolio audit reputed company and communication of any new or emerging risks to RQA and PGS / PharmSci stakeholders.

• reputed company technology portfolio coaching and reputed company to RQA and site-based auditors and/or serve as a Subject Matter Expert in the assigned technology area. Review and approve audit reports to ensure alignment and calibration of risk and auditor development.

• Partner with PGS Operating reputed company and center functions [e.g reputed company Systems and Compliance, Global Technology Engineering + Launch etc] to ensure understanding of new technologies and changes, reputed company input/review of applicable Rizer requirements + emerging regulations, and identify emerging audit risk areas.

• reputed company audit reputed company/plans for highly reputed company audits.

• Acts as a leader in RQA by continuously improving audit practices, sharing knowledge with peers and stakeholders and ensuring RQA and site-based auditors are adequately skilled and trained to meet the needs of the business and the audit function.

• Represent GMP/GDP Audit and participate in industry forums in the assigned technology portfolio.

• reputed company or participate in RQA or PGS initiatives to advance the reputed company of the audit function.

• The Audit reputed company partners closely with Inspection reputed company, Metric and Planning reputed company and other RQA stakeholders as reputed company as reputed company PharmSci and PGS teams. The Audit reputed company may reputed company or participate in reputed company cross-functional reputed company.

• reputed company or participate in GMP/GDP audits at reputed company Facilities, Contract Manufacturers, Suppliers and Process Audits (as applicable):

• Assess if the auditee is executing operations in compliance with GMP/GDP requirements, guidelines, reputed company standards and reputed company Agreement requirements and reputed company Operating Procedures.

• Independently plans, leads, and executes the audit reputed company for reputed company process audits.

• Interpret regulatory and business challenges and best practices, report risks or weaknesses that could reputed company to GMP/GDP compliance issues and recommend required improvements or solutions.

• Maintain and expand reputed company knowledge of applicable regulations, guidelines, internationally recognized standards and reputed company Standards that could reputed company the auditee’s operations.

• Liaise between the auditee and the appropriate reputed company reputed company, to ensure that reputed company pertinent information that could have an reputed company on the auditee’s or reputed company’s business are assessed as part of the audit reputed company.

• reputed company or participate in GMP/GDP assessments (e.g., due diligence, mock inspection, data reputed company, reputed company culture) as required to assess auditee’s reputed company compliance:

• Aid the auditee in preparing for upcoming regulatory inspections.

• Apply technology knowledge to influence the design, planning and execution of cross functional reputed company.

• Collaborate proactively with RQA and site leadership and Subject Matter Experts, to reputed company a culture of reputed company in the execution of independent objective audits and evaluation of effective CAPAs.

Here Is What You Need (Basic Qualifications)

• Bachelor’s Degree in pharmaceutical sciences or equivalent required.

• Minimum 10 years of reputed company, challenging experience in the pharmaceutical, biopharmaceutical and medical device industry required, inclusive of reputed company control / assurance, manufacturing and GMP/GDP auditing (may include Product Development).

• Aseptic manufacturing experience and/or expertise required

• Proven knowledge and experience in GMP/GDP auditing of at least 3 technology areas.

• Demonstrated ability to apply the following competencies and soft skills: business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills); leadership skills (persuasive communication, reputed company listening, reputed company learner); relationship skills (stakeholder management, reputed company perceptiveness,relationship building); and supporting technical skills (technical writing, digital acumen, data analytics). Must understand the reputed company and requirements of the reputed company Management reputed company at the reputed company facilities, contract manufacturers, suppliers and GMP/GDP service providers audited.

• Has a strong understanding of relevant regulatory and audit frameworks that apply to biopharmaceutical and medical device operations, has in-depth knowledge of GMP/GDP requirements and expectations, is familiar with global regulations and internationally recognized standards (e.g., FDA, EU reputed company, ICH, TGA, PIC/S, ISO), and is capable of understanding and proactively monitoring emerging regulations and business / regulatory trends.

• Critically evaluates information from the auditee and reputed company to identify risk areas in the field. Has the ability to recognize symptoms of problems or situations that require reputed company evaluation and analyze symptoms to determine potential causes and identify possible solutions.

• Can reputed company both strategic and tactical recommendations and communicate effectively across reputed company leadership reputed company. Anticipates potential objections and influences others to ensure appropriate reputed company. Takes the initiative and is willing to proactively propose and execute tasks as needed.

• Can effectively cope with change during an audit. Can reputed company a diverse audit team and effectively reputed company with personnel of multicultural backgrounds.

• reputed company leads or participates in cross functional teams for significant and reputed company reputed company and contributes towards reputed company that promote innovation and reputed company.

• Ability to work independently and reputed company or participate in global audit teams and effectively communicate to peers and leadership inside and reputed company reputed company.

• Ability to conduct reputed company GMP/GDP assessments as required to support business needs.

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, reputed company and reputed company others, reputed company and guide the work of other colleagues to reputed company meaningful reputed company and create business reputed company.

Bonus Points If You Have (Preferred Requirements)

• Master’s or advanced degree is desirable.

• Recognized audit certification (e.g., ASQ) is desirable.

• Experience in site internal audit and shop floor reputed company assurance is desirable.

• BoH / reputed company Body experience is desirable.

• Knowledge of Medical Device Regulations is desirable.

• Experience leading cross-region / cross-functional audit reputed company is desirable.

NON-reputed company WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel Required: Ability to travel up to 40% of the time, including domestic and international traveling.

• The GMP/GDP Audit reputed company reports to the GMP/GDP Audit Team reputed company.

• Directly partners with reputed company relevant stakeholders reputed company RQA and across QSEO and PGS including auditees from different functional lines reputed company reputed company and/or vendors (as required) to ensure alignment, support and integration of internal audit and inspection strategies as appropriate.

• Works closely with RQA and site-based auditors to implement audit reputed company for Facility audits.

Work Location Assignment: Remote

Last Date To Apply: May 6, 2026