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Sr Manager, Global Controlled Substance Audit Lead

Employer
Pfizer
Location
Remote, Remote, United States;
Salary
Competitive
Closing date
Dec 11, 2022

View more

Discipline
Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Manager
Organization Type
Pharma
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ROLE SUMMARY

The Global Controlled Substance Audit Lead is responsible for the planning and execution of Pfizer's Controlled Substance Audit Program (Level 1) at all sites that handle controlled substances including PGS and WRD facilities, contract manufacturing sites (CMO) and third-party distribution (3PL) sites globally to ensure all sites are maintaining a high level of compliance to company SOPs and government regulatory requirements.

ROLE RESPONSIBILITIES
  • Actively monitor and ensure compliance with all global controlled substance regulations, local laws/rules, and applicable corporate policies, standards and site level SOPs.
  • Responsible for managing and scheduling L1 audits at PGS, WRD, CMO and LSP sites through on-site, remote or electronic questionnaires depending on assigned site risk levels.
  • Approves and monitors corrective actions from audit activities to completion.
  • Provides audit metrics on a monthly basis including findings and corrective actions.
  • Maintains the controlled substance risk assessment and updates the global controlled substance site information on a yearly basis.
  • Serve as point of contact for controlled substance L2 audits by RQA and L3 audits by RDS.
  • Creates the yearly L1 audit schedule and ensures that all sites with controlled substances are audited every 4 years.
  • Creates and manages an Auditor training certification program for CSCF colleagues. Assigns auditors within the CSCF team to conduct the global audits at over 100 sites.
  • Establish & actively manage strong performance-based relationships with CS Network and changing controlled substance regulations, clearly defining compliance expectations for sites.
  • Creates and edits controlled substance questionnaires and audit tools as necessary.
  • Reviews audit reports prior to publishing and ensures that corrective action plans are appropriate. Works with site contacts to ensure corrective actions are addressed in a timely manner.
  • Reviews findings with L1 Auditors prior to closeout and ensures that findings are corrective actions are consistent across the global network. Attends L1 Audit closeout meetings virtually or in person to review findings with site leadership.
  • Supports site audits by regulators when needed.
  • Interact with Regulatory Officials globally as required.


Responsible for:
  • The communication of Controlled Substance audit activitiesto CS Network lead and site leadership;
  • Organizing internal and external resources to conduct audits;
  • Providing expert counsel for addressing issues that impact Pfizer's compliance with controlled substance and GMP requirements;
  • Identifying and acting upon opportunities to promote and strengthen Pfizer's relationship with regulators and/or our customers;
  • Escalating issues to management in a timely manner;
  • Participating in and providing metrics at global, regional and local meetings related to controlled substance audits.


BASIC QUALIFICATIONS
  • Bachelor's Degree in related field with 7+ years of related industry experience in handling controlled substances or GMP audits OR
  • Master's Degree in related field with 6+ years of related industry experience in handling controlled substances or GMP audits
  • Experience working in pharmaceutical industry.
  • Experience leading an audit program, including developing risk assessments, audit schedules and training curricula.
  • Experience with controlled substances and listed chemical requirements is required.
  • Must have sound knowledge of product lines, processes and associated technologies to effectively facilitate communication with stakeholders.
  • Previous experience in regulatory interpretation of government regulations via compliance and/or regulatory affairs positions is necessary.
  • Must possess ability to think strategically, strong attention to detail and ability to problem solve.
  • Must operate with highest level of integrity, professionalism and exhibit sound judgement at all levels.
  • Proficient in MS Office Applications (i.e., Excel, PowerPoint, Word, Outlook).
  • Strong oral and written communication skills.
  • Comprehensive/Working knowledge of Drug Enforcement Agency (DEA) regulations with particular emphasis on Schedule II, all controlled drugs and listed chemical requirements.
  • Experience interacting with State and Federal regulatory officials.
  • Knowledge and experience in DEA required records (e.g. DEA Forms 222, 236, 357, 161, etc.).
  • Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with State and Federal regulations.
  • Knowledge and experience in conducting CS investigations.
  • Ability to analyze and troubleshoot issues, identify CAPAs and proposed actions.
  • Knowledge and experience in reviewing CS SOPs to ensure CS requirements are met.
  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.


PREFERRED QUALIFICATIONS
  • Master's Degree preferred.
  • Auditor certification (ASQ or similar).
  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements.
  • Regulatory experience in controlled substance handling outside of the U.S.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • May require as much as 20% travel
  • Work Location Assignment:Remote


Last Day to Apply: 09 DECEMBER 2022

Relocation assistance may be available based on business needs and/or eligibility.

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.

Regulatory Affairs

#LI-Remote #LI-PFE
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