Manager Operations Professionals
Manager Operations Professionals
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$ 102900 - 171500
1 Vacancy
Job Description
Use Your Power for Purpose
The Manager Operations Professional in the MDCP Focus Factory will oversee a team that supports product operations with a key focus on qualityrelated requirements for the Focus Factory and driving improvements to processes while ensuring full cGMP compliance. The team will provide support for corrective actions continuous improvement drive change controls QAR authoring and documentation updates to support production needs and improvements. In this role you will be able to positively impact process improvements cost improvement initiatives and operational reliability.
The Manager will be accountable for audit responses on time deviation closures true root cause determination CAPA closures procedure and batch records revisions and all other GMP documents that require updates. This role will work in strong partnership with all roles within the Focus Factory as well as with the Quality Operations organization.
In this role you will drive efficiencies in the overall manufacturing system. The position will lead and support necessary change control to facilitate these process improvements. Your strong organizational and leadership skills will allow you to effectively coordinate and prioritize initiatives and activities to ensure on time delivery and prioritization of all activities.
You will report into the MDCP Focus Factory Leader.
It is your dedication and hard work that will make it possible for Pfizers customers and patients to receive the medicines they need when they need them.
What You Will Achieve
Manage team to deliver on activities such as CAPAs audit responses change control and planned temporary changes
Manage workload and prioritization to ensure adherence to on time record closure process including escalation of roadblocks which could result in delays.
Provide overview of investigations during regulatory inspections internal audits and customer audits and respond to verbal and written inquiries.
Actively identify and implement improvements in manufacturing procedures or processes. Apply operational excellence tools supporting continuous improvement to deliver measurable gains/efficiencies.
Oversee walkthroughs GEMBAs audit readiness activities
Conduct risk assessments APR trend analysis and aseptic events management as needed
Ensure ontime closures CAPA rates quality metrics and lot release
Maintain compliance and best practices including CAPA mitigation plans and compliance priorities for the focus factory
Guide and supervise document changes related to operations training production documentation deviation support CAPA management SOP updates batch record updates and regulatory audits
Lead and support process improvements change control and new product introductions
Ensure robustness of investigations through application of the DMAIC methodology and ensure identification and implementation of effective CAPAs to support reduction in deviations.
Participate in and support IMEX processes (Visual Management Standard Work CI
Maintain a culture of compliance and innovation with production processes.
Direct and support SOP and batch documentation generation/updates resulting from feasibility line trials engineering runs validation studies regulatory submission data and commercial launch planning.
Here Is What You Need (Minimum Requirements)
BA/BS degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR
a PhD with 0 years of experience; OR an associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Strong project management skills.
Excellent communication and leadership abilities.
Strong experience with cGMP pharmaceutical manufacturing in area of production quality assurance technical services or engineering.
Selfmotivated and able to adapt to rapidly changing priorities.
Strong oral and written communication skills and the ability to effectively manage project timelines through direct and indirect influence.
Ability to share vision direction and data with colleagues across all levels and in a wide range of different work groups.
Technical writing and problemsolving skills required.
Demonstrated ability to act decisively and independently to resolve issues
Bonus Points If You Have (Preferred Requirements)
Advanced qualifications in production management compliance and operational optimization
Audit (FDA/EMA/MHRA) experience as well as exposure to multiple sites/practices strongly desired.
Experience leading other leaders strongly desired.
Drug Product Operations experience highly desirable.
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform tasks such as lifting sitting standing walking bending
Oversees data analysis to support business development continuous improvement and quality responsibilities.
Candidate will be general gowning training and execute responsibilities according to area specific procedures.
Remains organized & positive in ambiguous and fastpaced rapidly changing situations
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
May include nonstandard work schedules travel and adherence to safe work practices and procedures
Available to provide oncall support during weekends and after working hours
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 providers 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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Manager
Employment Type
Full-Time
