Team Leader / Senior Manager Operations Compliance Value Stream

Pfizer Mcpherson , KS 67460

Posted 4 months ago

ROLE SUMMARY

This position reports to the Director of Drug Product Operations at the McPherson site. The position is a leader of leader, responsible for a sizable multi-shift team. Key accountabilities include operations management of teams and individual contributors in the support of product operations. Key focus is oversight of quality related requirements for operations areas and driving improvements to processes and the manufacturing facility to assure full cGMP compliance. Team will provide SME leadership and support for product/project introduction, technical problem solving, safety and compliance leadership, as well as training and documentation services to support production needs.

The Team Leader/Senior Manager, Operations Compliance Value Stream is accountable for the strategic planning, oversight and delivery of support functions to optimize compliance and productivity across McPherson Drug Product Operations. Working in strong partnership with Engineering, Technical Services, Quality, Safety and Operational Excellence, this Leader provides core support to the overall compliance and success of operations teams. Candidate must have experience in fill and finish production operations as well as a deep understanding of cGMP and regulatory requirements. The successful develop an organizational structure, optimize associated processes in adherence with cGMP requirements, Quality Standards, and other regulatory requirements, and implement an operations team to support production processes and continuous improvement activities.

ROLE RESPONSIBILITIES

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

  • Operations Training

  • Production Documentation

  • IMEx Implementation and Support

  • Lean/Six Sigma Initiatives

  • Aseptic Compliance

  • Regulatory Audits

  • This leader is accountable for SME support of new and/or transfer product processes, maintaining a culture of compliance and innovation with production processes.

  • The leader will guide an 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.

  • Provide direct support for regulatory compliance and qualifications.

  • Support regulatory audits.

  • Coordinate activities and develop initiatives to meet current and long terms compliance requirements. This includes providing input to Master Planning activities.

  • Build appropriate systems and support structure to support production processes.

  • Partner with and build strong, collaborative relationships with all Quality organizations, Safety, Training and Operational Excellence teams.

BASIC QUALIFICATIONS

  • Bachelor degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy, or related science with a minimum of 7 years of relevant experience or Master's degree with 5 years of relevant experience.

  • Strong experience with cGMP pharmaceutical manufacturing.

  • Self-motivated 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.

  • Prior management experience (minimum of 5 years) including working with cross functional teams.

  • Proven track record of delivering results consistently while being a role model for the Pfizer Leader Behaviors.

  • Thorough knowledge of continuous improvement methodologies, including lean/six sigma skills.

PREFERRED QUALIFICATIONS

  • 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.

  • Demonstrated skill in leading, operational planning, integrating, managing and/or coordinating similar/related teams, units, work processes or functions.

  • Comprehensive demonstrated skills in facilitating trust, understanding, growth, empowering and enabling employee, business and customer relationships.

PHYSICAL/MENTAL REQUIREMENTS

  • Due to the size and scale of the facility, substantial walking is required.

  • Must complete appropriate mathematical calculations to support budget and capital planning responsibilities.

  • Oversees complex data analysis to support business development, continuous improvement and quality responsibilities.

  • Candidate will be required to gown and execute responsibilities according to area specific procedures.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Position will also entail occasional off-shift and weekend work.

  • Travel or other Pfizer sites and/or vendors may occasionally be required.

  • This position will operate primarily on first shift, but may have direct reports on all shifts.

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.

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.

  • Last Date to Apply: October 10, 2018

  • Eligible for Employee Referral Bonus

  • Eligible for Relocation Package

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


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Hospital Construction Project Manager

E-Health Jobs

Posted 2 days ago

VIEW JOBS 12/11/2018 4:01:17 AM 2019-03-11T04:01 Senior Project Manager will support all physical plant construction, renovation, restoration, and major repair programs at any facility within the national health system. This position is knowledgeable in building systems and construction methods specifically in a health care environment. This position develops concepts and plans for facility growth or change in service as well as capital upkeep and replacement. The key role of this position is advisor to each individual facility managing director to assist in growth planning and implementation, as it relates to buildings and facility campus. This position has responsibility to oversee other Assistant PM and Regional PM as assigned to provide guidance on project decisions and regulatory interface. A Mentoring relationship will be required. Essential Job Duties Work closely with RVP, C-suite, RFM/DPO, FF&E and IT in the development of project scope and price. Differentiates between priority business needs and "nice-to-have?s" in order to assist in determining project priority and to resolve resource conflicts. Works closely with user groups to learn all aspects of user requirements in order to provide effective advice and recommendation. Ensure projects are completed on budget and schedule and that the projects incorporate the latest Behavioral Health/Acute best practices. Have the ability to manage multiple, large projects at one time with some supervision. Develop/engage project teams using a competitive RFP process. Assist in guiding project through local, State and Federal building restrictions and code compliance. Accurate budgeting, scheduling, logistics, ICRA, ILSM from conception through completion. Follow the CAR/PAC process for pre-validation, validation and request for full funding. Take a leadership role in finding new methods/approaches to help execute work faster and more efficiently. Challenge assumptions and bring new ideas to the table that could benefit the entire department in executing our role. Maintain a vendor ranking and ensure we reinforce success by re-engaging firms that perform excellent work and value the relationships in the system. Collecting historical cost and schedule data to utilize in predicting future cost and time to execute projects (send to corporate at projection completion). Ensure all parties on the project have executed a contract and have provided all the required insurances prior to commencing work. Ensure the highest ethical standards when dealing with our vendors. Ensure vendors compliant with the terms of the agreement and that the business terms agreed are fair to both the vendor. Use business term guidelines. Job Requirements Bachelor's degree, Master's degree preferred. At least 5 years of hospital construction experience required Travel 25% to 50%; strong leadership skills; specific construction implementation experience, some development experience, code and permit knowledge, negotiating skills, strong interpersonal skills to lead vendors, solid business decision making skills. E-Health Jobs McPherson KS

Team Leader / Senior Manager Operations Compliance Value Stream

Pfizer