Senior Manager, Corporate Audit (GMP)

Corporate Audit offers exciting, dynamic and rewarding opportunities to leverage your technical competencies and experience into a work product that serves to inform the highest levels of Pfizer’s governance. You will apply your talent to uncover, identify business, regulatory and reputational risk and assess the state of risk mitigation. In doing so, you will also gain access to, and learn from, site and corporate thought leaders across Pfizer’s business lines.

The Sr. Manager, Corporate Audit is responsible for planning, leading and conducting independent audit and risk oversight activities primarily related to regulated pharma manufacturing. These audits provide an independent assessment of the design and operating effectiveness of controls and compliance with regulations, internal policies and procedures, and good business practices. Additionally, this individual interfaces with business representatives and makes recommendations for risk mitigation.

ROLE RESPONSIBILITIES:

Audits

1. Assists with the identification of audit topics to be included within the audit universe.

2. Provides fact-based input into the risk assessment and selection of audit targets.

3. Leads scheduled audits in accordance with Corporate Audit processes, as well as other oversight activities (e.g., assessments, compliance investigations) as assigned.

4.  Identifies ways to improve audit processes to ensure appropriate assessments of controls in an evolving business model.

Relationship Management

1. Works within functional area to ensure efficiency and consistency in approach and to minimize gaps and redundancies in activities.

2. Cultivates strong relationships within Corporate Audit to achieve an effective oversight program.

3. Uses compliance and business intelligence to forge relationships critical to a comprehensive oversight program.

4. Recommends approaches for oversight activities to mitigate risks across the assigned business line.

5. Create and sustain a long-term relationship with our stakeholders as a credible and reliable advisor for risk management and improvements.

Other Activities

1. Maintains high level of awareness of changing needs of the business, industry trends, competitive activities, and regulatory environment.

2. Takes on special projects at the request of management.

3. Serves on Corporate Audit departmental committees/teams, as necessary.

4. Assists in the development/updating of Corporate Audit departmental standard operating and administrative procedures.

5. Serves as a resource on regulated pharma manufacturing compliance matters.

QUALIFICATIONS:

REQUIRED BASIC QUALIFICATIONS:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field.
• Technical expertise and 10 or more years of regulated pharma manufacturing experience in one or more of the following areas:
  • Developing and maintaining programs and processes required for regulatory compliance.
  • Quality experience
  • Risk assessment and audit experience, i.e. identifying risks within a given discipline and auditing against those risks
• A thorough understanding of internal regulated pharma manufacturing policies, standards and systems.
• Pharma industry experience
• Demonstrated high learning agility with disciplines beyond area of expertise
• Experience working in dynamic complex business models (e.g., outsourcing and partnerships)

PREFERRED QUALIFICATIONS

• Advanced degree in Life Sciences, Chemistry, Engineering, or related field.

Other Skills

• Demonstrated ability to apply knowledge of regulations, policies and standards to assess compliance.
• Demonstrated team leadership and project management skills
• Ability to assess systems and processes in a highly systematic manner and make conclusions based on sound judgment and experience in order to identify and articulate gaps and potential risk
• Excellent written and verbal communication and presentation skills
• Excellent interpersonal and negotiation skills, with a demonstrated ability to effectively interact with clients, influence others, identify compliance gaps, and communicate pathways for corrective/preventative actions
• Ability to create a strong collaborative environment working with all levels of management
• A self-starter who holds themselves and others accountable
• Ability to travel (both domestic and international) up to 30%.

  
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate