Pfizer Site Leader in St. Louis, Missouri
The Meridian Site Leader provides leadership, strategic direction, and tactical oversight to the facility, in alignment with the GSI (Global Sterile Injectables network within Pfizer) Culture and Values. This includes all combination product production operations and the related support functions directly or indirectly (Operations, Utilities & Maintenance, Engineering & Technical support, Quality, EHS, Supply Chain/Warehousing, Finance, Procurement, Site transformation/OE, Product Life Cycle Management).
Primary accountabilities include developing and executing operating plans that lead to the achievement of the sites' mission and ultimately those of Meridian; making effective financial and operational decisions to positively impact the short and long-term plans of the site commercial goals of the products being manufactured at the site; developing and maintaining a cost effective, competitive organization through effective organizational design, workforce planning, leadership and talent development, external stakeholder management, objective setting, training, GMP compliance and performance management.
Provide strategic direction and leadership to the Meridian Medical Technologies combination product manufacturing site (St. Louis Operations) located in Richmond Heights and Maryland Heights Missouri
Develop and execute operating plans that lead to the achievement of the site, customer, product and Meridian goals.
Provide direction and leadership for all site operations including but not limited to: Manufacturing, Quality Operations, Supply Chain/Logistics, Product and Process Technology, Strategic Planning and Product Introduction, Operational Excellence, Engineering, and EHS.
Since the Meridian organization is unique within Pfizer and is mapped from a budget perspective into HBU (Hospital Business Unit); foster and maintain key linkages within PGS (Pfizer Global Supply) and supporting functions in order to ensure full alignment of St. Louis operations with all key Pfizer manufacturing standards, programs and expectations.
Ensure site compliance (Quality, EHS, and Financial for example) and that related risks are effectively addressed/mitigated in support of all relevant regulations. This includes but not limited to international combination product regulations, cGMP's and Pfizer Quality Standards.
As a key member of the Meridian leadership team; ensure manufacturing is properly aligned in support of overall organizational objectives and commercial requirements.
Certain products manufactured and/or packaged at this site are subject to EAR-600 trade controls. The Site Leader has certain key responsibilities under this law and is responsible for ensuring that all site colleagues (and visitors where required) are properly trained and fully comply with specific EAR-600 requirements.
Communicate effectively with various stakeholders, including but not limited to: other areas within Pfizer supply network, external suppliers, local community and political entities, Pfizer colleagues, and legal organizations.
Develop and maintain effective relationships with internal and external customers, regulators and other stakeholders including Teamster Local 685 representatives and leaders.
Develop and maintain a high performing organization through effective selection, training leadership and management.
Manage colleague performance and development.
Support and foster operational excellence across all functions - including Integrated Manufacturing Excellence - IMEx - implementation.
Demonstrate and ensure that the highest levels of ethics and integrity are fundamental to the organization.
Support strategic acquisitions and/or partnerships as required.
Make effective financial and operational decisions to positively impact both short and long term site goals.
Create, establish and maintain an environment that encourages teamwork, ownership, empowerment and commitment at the site.
Take an active leadership role representing the site and company in the local community.
"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."
Must have experience working in pharmaceutical manufacturing in sterile injectable operations.
Experience directly in Aseptic Operations is highly desirable.
Experience with medical device product manufacturing and development highly desirable.
Experience with Combination Products (as defined in 21 CFR 3.2(e)) required.
Must have strong operational excellence experience and skills
Financial controls and practices as appropriate for site management
Bachelor's degree in chemistry, engineering, or a related technical or business discipline
Master's degree preferred
At least 15 years directly related experience in pharmaceutical manufacturing, combination product or medical device manufacturing, including at least five years of experience leading a major manufacturing or quality operations function in a manufacturing plant. Multi-national experience highly desired.
Strong understanding of cGMPs specifically aseptic manufacturing and demonstrated success leading GMP-compliant operations and interacting with regulators.
Strong understanding of Combination product and medical device regulations including QSR 820
Knowledgeable of FDA compliance regulations
Excellent verbal, written and interpersonal communication skills
Languages: English fluency
Demonstrated aptitude and attitude to get immersed in the resolution of technical challenges and technical advancements.
Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.
Demonstrated ability to plan, implement, and achieve significant, complex goals and objectives.
Ability to influence and lead at all levels of the organization
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Meridian Medical Technologies, Inc. ("Company") must comply with U.S. export control laws. Under these laws, the release or disclosure of U.S. origin controlled technology to foreign nationals is deemed to be an export to the foreign national's home country. Employment at the Company may allow access to Controlled Technology regulated by U.S. export control laws. As such, a U.S. export authorization may be required to support your employment.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
Other Job Details:
Last Date to Apply for Job: March 16, 2021
Eligible for Relocation Package: Yes
Eligible for Employee Referral Bonus: Yes
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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.