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Senior Manager, ARD Compliance

Employer
Pfizer
Location
Andover, Massachusetts, United States;Durham, North Carolina, United States;
Salary
Competitive
Closing date
May 25, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best - in - class medicines to patients around the world.

What You Will Achieve

In your role, you will be at the center of Pfizer's operations and you will find that everything we do, every day, is in line with an unwavering commitment to quality. Your work will help Pfizer in the critical area of portfolio management for our Research and Development (R&D) function. You will work as part of a team which designs and implements business processes to enable product research and development, portfolio prioritization, resource allocation and risk management.

The Sr Manager, Analytical Compliance will lead the delivery of the analytical quality control compliance, instrumentation, and the data integrity strategy for Biotherapeutics Analytical Research and Development. This role will interface with the multiple analytical functions as well as strategic partners such as Quality Assurance, Digital Strategy, Pfizer Global Supply and various support services to ensure compliance with applicable procedures and policies and the implementation of a robust data integrity program. The candidate must be able to interact effectively with auditors, inspectors and inspection teams, highly interdisciplinary teams, and must work well in a cross functional environment. This candidate is accountable for leading the overall Analytical Quality Culture and maintaining an audit and inspection ready state (in partnership with Analytical Research and Development management).

Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.

It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

This role's primary function is to enhance the overall Quality Culture within Analytical Research and Development and drive compliance and quality standards. This role will support compliance with applicable SOPs, policies, and standards. This role could also include investigation authoring, responsible persons, CAPA management, change control oversight, quality system support, vendor support, instrument validation lifecycle support, and other compliance responsibilities.

The purpose of this position is to lead a strong compliance culture within Biotherapeutics Analytical Research and Development, and to maintain processes to drive high standards of data integrity, quality, and compliance. The candidate will proactively drive departmental initiatives to enhance the overall Quality culture and continue the development and implementation of the data integrity strategies across ARD and Pharm Sci. The candidate will interface with appropriate departments, functions and SMEs regarding compliance and data integrity related programs,questions, and communications.

This role will provide leadership during inspections and audits, including preparation of SMEs and topics, managing requests, partnering with the Quality Unit, and representing Pfizer with integrity. Accountability for continuous improvement initiatives for the Biotherapeutics Analytical Research and Development organization in areas such as data review, specification review and approval, change control, instrument systems, method and instrument validation and associated partnerships.

Additional responsibilities are/may be:
  • Managing compliance related metrics
  • Optimization and implementation of Pharmaceutical Quality System elements that impact or potentially impact Analytical Research and Development, including review and oversight.
  • The colleague must work within corporate guidelines and must appropriately record, archive, and report all data in a compliant manner. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team.
  • Lead audit/inspection and compliance strategy implementation efforts, including inspection readiness training, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
  • Support data integrity efforts as needed, including detection of potential gaps and partnership with laboratory personnel for remediation efforts.


Qualifications

Must-Have
  • B.A. / B.S. in biology, biochemistry, immunology, molecular biology, or related field
  • 10 plus years of experience with interdisciplinary drug development teams and industrial experience.
  • Significant experience with data integrity approaches and strategy is required.
  • Experience working in a regulated environment (e.g. GLP, cGMP).
  • Proven record of delivering results in a fast paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
  • Demonstrated technical writing skills.
  • Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.


Nice-to-Have
  • Direct experience working with regulatory authorities. Experience in GMP environment and implementation of continuous improvement practices.

    •Comfortable and effective in a team-based, fast-paced environment where multi-tasking required

    •A record of external presentations (oral, poster and/or publications) in relevant field

    •Verbal and written communication skills

    •Awareness of scientific literature


PHYSICAL/MENTAL REQUIREMENTS

Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some occasional travel to other Pfizer sites may be required. Overtime, off shift coverage, or holiday coverage, though rare, may be required.

Other Job Details

Relocation support available

Eligible for Employee Referral Bonus

Last Day to Apply: May 27, 2022

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

#LI-PFE
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