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Job Title: Site Quality Operations Leader
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Site Quality Operations Leader
**What You Will Achieve**
+ Oversees and assures overall quality/integrity of pharmaceutical products manufactured and distributed in worldwide markets based on cGMP regulations and industry standards.
+ This position establishes and maintains operational surveillance of manufacturing and packaging processes to insure compliance with established procedures and regulations.
+ •Implements strong communication networks for information flow to and from the plant, senior management, staff groups and regulatory agencies. This includes a robust notification to management process.
+ Accountable for staffing, training & development, motivation & coaching, giving feedback and effective listening & communication towards his/her colleagues. The Senior Manager QO will respect the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, cGMP, customer satisfaction, right first time and cost. The leader focuses on the departmental objectives in support of the site and the PGS objectives.
+ Hosts regulatory inspections and responds to regulatory observations and questions both verbally and in writing.
+ Stays current with company policies and operations, current Good Manufacturing Practices, federal regulations, and compendial requirements.
**How You Will Achieve It**
+ Assures overall quality/integrity of pharmaceuticals products manufactured and distributed in worldwide markets based on cGMP regulations and industry standards.
+ Provides leadership for the Quality unit responsible for compliance, documentation and laboratory operations, including 4 or 5 managers.
+ Ensures establishment, implementation and adherence to quality pharmaceutical manufacturing standards.
+ Assures that all processes, systems, facilities, methodologies utilized in the manufacture/testing of pharmaceuticals are validated and fully integrated.
+ Establishes systems to assure the audit readiness of manufacturing /testing facilities by regulatory agencies and internal auditors.
+ Implements strong communication networks for information flow to and from the plant, senior management, staff groups and regulatory agencies. This includes a robust notification to management process.
+ Actively engaged in location leadership and site leadership initiatives.
+ Interacts with diverse stakeholders to achieve site goals such as groups from regulatory, GTS, Pharm Science, PGRD, OpEx, NP and Quality Center.
+ Lead and engage the Site Quality Review Team (SQRT) and contributes to the Area Quality Review Team (AQRT) to assure compliance to worldwide standards.
+ Active member of Site Leadership Team to assure supply, financial commitments and consistently achieve common site goals.
+ Fosters a culture of continuous improvement and innovation at the site, and play a lead role in protecting and strengthening the site quality culture.
+ Demonstrates a passion for Colleague Engagement and is an active change agent.
+ Accountable for staffing, training & development, motivation & coaching, giving feedback and effective listening & communication towards his/her colleagues. The Sr Manager QO will respect the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, cGMP, customer satisfaction, right first time and cost. The leader focuses on the departmental objectives in support of the site and the PGS objectives.
+ Engaged in the external regulatory community.
+ Liase with other site QO leaders and Center QO to ensure aligned direction and response on specific topics at the Rochester site.
+ Keeps abreast of business and industrial conditions and broadens his/her knowledge of pharmaceutical production practices, regulatory, marketing requirements and company operations to focus on best practices for the Rochester site. Ensures adoption and sharing of best practices across the Pfizer network.
+ Keeps abreast of evolutions in pharmaceutical production practices, regulatory requirements and company operations and cGMP's affecting all aspects of the pharmaceutical industry.
+ Has a reporting relationship to Operating Unit QO Leader.
EDUCATION AND EXPERIENCE:
+ BS in Science, Engineering or a related field is required. MS, MBA or Ph.D. in Pharmaceutical related field preferred.
+ Minimum of ten years of broad-based experience working in the pharmaceutical industry with at least five years working in QA/QC management position.
+ 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.
TECHNICAL SKILLS REQUIREMENTS:
+ Strong knowledge in Aseptic Pharmaceutical processes and technologies.
+ Demonstrated leadership, management and technical capabilities.
+ Strong verbal, written and interpersonal communication skills.
+ Deep knowledge of local, federal and international regulations applicable to the pharmaceutical/API industry.
+ Demonstrated success interacting with regulators.
The work environment characteristics and physical demands described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually low to moderate.
NOTE: Successful candidate must not be allergic to penicillin.
**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**
+ May require weekend or off-shift work.
+ Last date to apply: 6/10/22
+ Relocation support available
**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**
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.
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