Pfizer Compliance Manager in McPherson, Kansas

ROLE SUMMARY

This position is responsible for managing the site Internal and External Audit programs, interpreting the global GMP regulations / guidelines and the Pfizer Quality Standards and ensuring that the site remains compliant with these requirements. The Compliance Manager will ensure the site's sustained inspection readiness by directing a team of audit (internal/external) and inspection readiness professionals. This position interfaces routinely with global regulatory agencies, Pfizer Centre One customers, and above-site PGS leadership.

ROLE RESPONSIBILITIES

  • Manage Internal Audits and the site Quality Assurance Self-Assessment (QASA) program to include scheduling, mentoring auditors, approving QASA reports etc.

  • Lead preparation and/or facilitation of regulatory/customer inspections

  • Ensures processes associated with sustaining an inspection readiness state are maintained, including but not limited to: Maintain Site Regulatory Inspection Plan, Develop and Provide Inspection Readiness Training, Ensure individuals are trained in inspection readiness process, provides clear understanding of roles and responsibilities to sustain an inspection readiness state

  • Remain up-to-date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines) as well as Pfizer Quality Standards. Communicate to the network key learnings at any of our sites through a regulatory audit or emerging regulations. Input could be from our own network (inspections, complaints, internal audits) or from external regulatory intelligence (WLs from other companies, emerging regulations).

  • Oversee regulatory commitments and health authority queries. Manage site responses to external audit observations.

  • Lead site Inspection Readiness Program and team of quality professionals

  • Management of action items generated from internal Audit & QASA.

  • Work with Pfizer Global Supply groups (center functions, other sites) as needed.

  • Other duties within the quality department as required.

BASIC QUALIFICATIONS

  • Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy

  • A minimum of 5 years quality/regulatory experience with at least 1-2 years managing quality/regulatory programs and organizations in the pharmaceutical and/or food industry.

  • Requires 2 years supervisory experience.

  • Experienced in auditing with GMP regulated industries required.

  • Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) required.

  • Knowledge of Quality Systems in pharmaceutical industry

  • Effective communications skills required, both written and verbal.

  • Requires strong interpersonal skills and the ability to handle multiple projects.

  • Fluent in English both speaking & writing

  • Good knowledge of MS Office

PREFERRED QUALIFICATIONS

  • ASQ Certified Quality Auditor is preferred.

  • Experience in aseptic manufacturing is preferable

PHYSICAL/MENTAL REQUIREMENTS

Problem solving skills are required in the following day to day activities: situations that are not procedurally managed, hosting audits, and conducting and responding to observations from regulatory agencies and third party customer auditors. Ensures that actions taken to resolve audit observations are on schedule and completed in a timely manner.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

  • Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

  • Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

  • Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

Other Job Details:

  • Last Date to Apply for Job: January 22, 2019

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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.