Manager Of Operations Compliance

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.

What You Will Achieve

This position reports to the Senior Managers in Vaccine Drug Substance at the Sanford site. The position is responsible for maintaining compliance, inspection readiness, cGMP auditing, right the first-time manufacturing, interactions with internal and external Regulatory agencies (FDA, EMEA, etc.) Key focus is the oversight quality related requirements for operations areas and driving improvements to processes and the manufacturing facilities to ensure full cGMP compliance.

Will be responsible for leading CI teams and provide SME leadership to support product / project introductions, technical problem solving, safety, human error reduction, compliance leadership, as well as training and documentation improvements to support production needs. Will be the manufacturing single point of contact for technical services in the validation (equipment and cleaning) of manufacturing equipment across all vaccine manufacturing trains. Must be knowledgeable of Operations across all 3 trains of Vaccine manufacturing.

The Manger of Operations Compliance is accountable for strategic planning, oversight, and delivery of support functions to optimize compliance and productivity across Sanford Vaccine Drug Substance Operations. Working in strong partnership with Engineering, Maintenance & Utilities (EMU), Technical Services, Quality, EHS, and Operational Excellence. This leader will provide core support to the overall compliance and success of the 24/7 operations team. Candidate must have experience in DS manufacturing operations to include knowledge of manufacturing equipment / procedures, auditing, cGMP documentation practices, and experience supporting and interacting with Regulatory inspectors. Will accompany internal and external Regulatory auditors and interact with agencies during cGMP inspections. Will provide and assist in audit responses. Formal experience in the Quality organization is highly desired.

How You Will Achieve It

Develop and implement structure and associated processes for an operations focused team to support and drive activities related to:

• Right first-time production.

• Inspection readiness to lead to zero audit observations.

• Reduction in human error to reduce process deviations, safety incidents, and batch loss.

• Lead CI teams to simplify process.

• Lead internal and external audits.

• Provide SME review of audit observation response.

The leader is accountable for SME support of new product transfers to ensure compliant startups.

The leader will guide and operations team through appropriate application of technical knowledge to troubleshoot activities, provide investigation support, analyze process data, and identify and implement process improvements in support of daily operations.

Technical Competencies

• Will review and analyze process data and perform mathematical calculations.

• Strong demonstrated knowledge of cGMP pharmaceutical manufacturing equipment and processes. Experience in trouble shooting equipment in cGMP environment.

• Demonstrated experience performing Data Integrity assessments and gap closure.

• Knowledge of CI methodologies.

Behavioral Competencies

• Self-motivated and able to adapt to rapidly changing priorities.

• Strong oral and written communication skills.

Organizational Reporting Structure

• This position reports to Senior Managers in Vaccine Drug Substance at the Sanford site.

• This position will have 0 direct reports, but potential to have 20 - 25 indirect reports to include manufacturing process engineers.

• Direct interactions across all Operations to assure compliant and timely delivery of products to customer base.

• Routine interactions with site functions to include the following: Quality, Site Engineering and Maintenance, Manufacturing Science and Technology, Technical Operations, Operational Excellence, Supply Chain, Finance, Business Technology, Procurement, and EH&S. Will interact and report out to Site Leadership Team include Site Leader and Site Quality Leader on a routine basis.

• Periodic interactions and communications with a wide range of Regulatory Agencies.

• Will conduct routine auditing of manufacturing colleagues to include aseptic gowning and aseptic practices.

• Will provide formal training of manufacturing colleagues to improve compliance and Regulatory standards.

Qualifications

BASIC QUALIFICATIONS

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.

• Strong demonstrated knowledge of cGMP pharmaceutical manufacturing equipment and processes. Experience in trouble shooting equipment in cGMP environment.

• Self-motivated and able to adapt to rapidly changing priorities.

• Strong oral and written communication skills.

• Experience (minimum 2 years) experience working with cross functional teams.

• Demonstrated experience performing Data Integrity assessments and gap closure.

• Knowledge of CI methodologies.

PREFERRED QUALIFICATIONS

• At least 2 years of formal Quality experience.

• Audit experience (FDA, EMA, MHRA).

• Equipment validation experience.

PHYSICAL/MENTAL REQUIREMENTS

• Self-motivated and able to adapt to rapidly changing priorities.

• Strong oral and written communication skills.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• May be required to work off-shift periodically (< 10%).

Other Job Details:

• Last Date to Apply for Job: May 24th, 2023

• Work Location Assignment:On Premise

• Relocation Support Available

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

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.

Engineering

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