Audit Lead

About the role

The GMP/GDP Audit Lead position is responsible for leading the design, delivery, and maintenance of audit strategy associated with one of the following key technology or business aligned areas: sterile biologic, medical device (including software as a medical device and digital health and medicines), small molecule, vendor, and GDP. The Audit Lead ensures that audit processes, systems, and procedures align with regulatory expectations and are effective at delivering robust evidence identifying risks and adapting to emerging advances, regulations, and industry trends related to the technology/business area. They also coach and develop both RQA and sites-based auditors.

Responsibilities

• Lead strategy, delivery, and maintenance of audits for technology or business areas.
• Develop and implement technology/business-focused audit strategy to ensure procedures and guidelines remain aligned with applicable regulations and remain current and effective at enabling identification of emerging risks.
• Analyze regulatory intelligence including emerging regulations and audit and inspection outcomes in the assigned technology portfolio to ensure audit focus areas remain relevant to emerging regulations and technology advancements.
• Ensure understanding and working knowledge of all applicable regulations and emerging regulatory trends for associated technology area.
• Review and approve audit reports to ensure alignment and calibration of risk and auditor development.
• Partner with Pfizer Global Supply (PGS) and Pharm Sci teams leading these technologies/business areas to ensure aligned expectations for GMP/GDP requirements and full understanding of Pfizer manufacturing and supply capabilities in these areas.
• Lead or participate in complex cross-functional projects.

Requirements

• Bachelor’s Degree in pharmaceutical sciences or equivalent required.
• Minimum 10 years of progressive, challenging experience in the pharmaceutical, biopharmaceutical, and medical device industry required, inclusive of quality 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 business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills); leadership skills (persuasive communication, active listening, active learner); relationship skills (stakeholder management, social perceptiveness, relationship building); and supporting technical skills (technical writing, digital acumen, data analytics).
• Must understand the elements and requirements of the Quality Management System at Pfizer 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 Directive, 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 able to identify risk areas in the field.
• Can make both strategic and tactical recommendations and communicate effectively across all leadership levels.
• Anticipates potential objections and influences others to ensure appropriate outcomes.
• Takes the initiative and is willing to proactively propose and execute tasks as needed.
• Can effectively cope with change during an audit.
• Can lead a diverse audit team and effectively interact with personnel of multicultural backgrounds.
• Actively leads or participates in cross-functional teams for significant and complex projects and contributes towards outcomes that promote innovation and excellence.
• Ability to work independently and lead or participate in global audit teams and effectively communicate to peers and leadership inside and outside the company.
• Ability to conduct ad hoc GMP/GDP assessments as required to support business needs.

Qualifications

• Bachelor’s Degree in pharmaceutical sciences or equivalent required.
• Minimum 10 years of progressive, challenging experience in the pharmaceutical, biopharmaceutical, and medical device industry required, inclusive of quality 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 business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills); leadership skills (persuasive communication, active listening, active learner); relationship skills (stakeholder management, social perceptiveness, relationship building); and supporting technical skills (technical writing, digital acumen, data analytics).
• Must understand the elements and requirements of the Quality Management System at Pfizer 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 Directive, 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 able to identify risk areas in the field.
• Can make both strategic and tactical recommendations and communicate effectively across all leadership levels.
• Anticipates potential objections and influences others to ensure appropriate outcomes.
• Takes the initiative and is willing to proactively propose and execute tasks as needed.
• Can effectively cope with change during an audit.
• Can lead a diverse audit team and effectively interact with personnel of multicultural backgrounds.
• Actively leads or participates in cross-functional teams for significant and complex projects and contributes towards outcomes that promote innovation and excellence.
• Ability to work independently and lead or participate in global audit teams and effectively communicate to peers and leadership inside and outside the company.
• Ability to conduct ad hoc GMP/GDP assessments as required to support business needs.

Skills

• Business skills (negotiation, logical reasoning, critical thinking, decision making, presentation skills)
• Led leadership skills (persuasive communication, active listening, active learner)
• Relationship skills (stakeholder management, social perceptiveness, relationship building)
• Supporting technical skills (technical writing, digital acumen, data analytics)

Benefits

• Comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

Pay

The annual base salary for this position ranges from $162,900.00 to $271,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share-based long-term incentive program.

Schedule

Non-standard work schedule, travel or environment requirements.