QO Manager Compliance/TL-Pfizer

Job Description

Job Title: QO Manager Compliance/TL

Company: Pfizer

Location: Rochester, MI

Pay: $102900 – 171500 per year

AI Pay Analysis: The hourly rate of $102,900 – $171,500 per year for the role of “QO Manager Compliance/TL” in Rochester, MI, translates to approximately $49.43 – $82.51 per hour. This salary range appears competitive, as it aligns with industry standards for quality assurance and compliance roles, especially in the manufacturing and technology sectors where such positions often require a blend of technical expertise and managerial skills. In Rochester, which is part of the Detroit metropolitan area with a cost of living slightly below the national average, this salary range seems robust, especially for a managerial position, making it an attractive opportunity for qualified candidates. Overall, the compensation appears to be well-positioned within the market, reflecting both the responsibilities associated with the role and the regional economic landscape.

Job description:

Use Your Power for Purpose

The selected candidate will assume a leadership role within the Rochester Quality organization, overseeing a dedicated team responsible for Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity.

Key responsibilities include providing guidance and coaching to Quality Operations colleagues, directing and approving various activities and decisions, and cultivating a positive workplace culture by reinforcing group values and behaviors. The candidate will monitor individual and team performance related to personal development and quality issues while conducting performance reviews and providing second-level assessments as necessary. Furthermore, oversight of departmental resources, including budget management and personnel allocation, is essential. Effective communication with key customers and partners, both within and outside the organization, is a critical aspect of this role.

This position requires collaboration across different departments and organizations, and active participation in internal, corporate, and regulatory audits/inspections. The candidate will monitor and present quality metrics during the Site Quality Review Team and Management Review meetings and lead the site’s Quality Improvement Plan (QIP) and Inspection Readiness Program (IR).

By bringing your dedication and expertise to this role, you will contribute to Pfizer’s ongoing success and elevate our capability to enhance patient outcomes globally.

In this leadership position, you will guide a team focused on a broad spectrum of quality responsibilities, including Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity.

Compliance, QA Documentation, and Supplier Management:
You will ensure that our site’s standards, policies, and procedures align with Pfizer’s global Quality Standards and comply with relevant regulatory guidelines. Maintaining inspection readiness will involve conducting internal audits, generating compliance metrics, and performing gap assessments to address any areas of non-compliance. Additionally, you will coordinate the supplier management program, oversee Medical Device & Combination Products (MDCP) activities, investigate product complaints, and prepare annual product reviews. The role includes managing the QA Documentation department, ensuring that standard operating procedures (SOPs), master batch records, specifications, test methods, on-the-job training documents, validation protocols/reports, and other Good Manufacturing Practice (GMP) documents are accurately maintained.

Validation and Sterility Assurance:
You will ensure that the site’s Validation and Sterility Assurance standards, policies, and procedures conform to Pfizer’s Quality Standards and relevant regulatory guidelines. Oversight responsibilities will encompass change control, validation efforts, quality risk management, and microbiological support for processing, cleanroom behaviors, environmental monitoring, and sterilization protocols. You will maintain programs such as the Validation Master Plan, change control, and sterility assurance assessments, and oversee the environmental and personnel monitoring programs to mitigate risks to product quality.

Combination Product Quality and Data Integrity:
This role involves ensuring the systems are in place to assess the impact on combination products and uphold Data Integrity. You will remediate gaps and maintain compliance between on-market products and the Design History File (DHF). Responsibilities include overseeing risk management file lifecycle activities, facilitating risk assessments for combination products, and managing technical guidance for related changes. You will lead the planning and implementation of comprehensive risk management strategies and will be responsible for the site’s Data Integrity Quality System, including the establishment of effective policies, procedures, and performance monitoring mechanisms.

Minimum Requirements:
Candidates must possess a bachelor’s degree with a minimum of 4 years of relevant experience; alternatively, a master’s degree with at least 2 years of experience, or a PhD with no experience may also be considered. Candidates with an associate degree and 8 years of experience, or a high school diploma and 10 years of relevant experience will also be taken into account. Experience within a cGMP environment is essential, along with a strong knowledge of quality systems and aseptic processes, particularly concerning Drug and Combination products. The ideal candidate will demonstrate exceptional organizational skills, the ability to manage multiple priorities, technical aptitude, and excellent problem-solving capabilities. A solid understanding of regulatory requirements and audit strategies, as well as specific knowledge of aseptic manufacturing processes, is highly desirable. Excellent written and verbal communication skills, with the ability to convey complex information to a diverse audience, including senior leadership and regulatory bodies, are crucial.

Physical/Mental Requirements:
Candidates must be aware that this is a penicillin manufacturing facility, and therefore, applicants must not have a penicillin allergy. The position requires the ability to aseptically gown and lift weights of 25-30 lbs.

Work Schedule and Location:
The role necessitates flexibility in work hours, which may include weekends or night shifts to support product release. Minimal travel for training and seminars may be required. This position is based on-site.

Compensation for this role ranges from $102,900.00 to $171,500.00 annually, with eligibility for Pfizer’s Global Performance Plan and a bonus target of 15% of the base salary, alongside participation in share-based long-term incentive programs. Pfizer offers a comprehensive benefits package, including a 401(k) plan with matching contributions, vacation, health coverage, and paid leave.

Pfizer is committed to diversity and inclusion and maintaining equal opportunity in employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. This position requires permanent work authorization in the United States.

Job Posting Date: Mon, 24 Mar 2025 06:06:12 GMT

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