Job description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
Responsible for the oversight of the CMC, Cleaning Validation, Product and Process Validation, Regulatory Audit Support and QO Technical Transfer functions at the Kalamazoo site. Ensures that the processes and procedures used meet external requirements from regulatory agencies throughout the world as well as internal Pfizer Quality Standards. Works with 3 QO managers to ensure their development as well as an extended team of over 50 staff and technicians. Prepares and justifies a multi-million dollar personnel and lab supply budget annually.
How You Will Achieve It
Leads the Chemistry and Manufacturing Controls (CMC) team, which are the site’s participants in the global regulatory change process.
Leads the site Regulatory Inspection team, which plans and implements the hosting and strategic support of audits. Also responsible for the site internal inspection program and inspection readiness programs.
Directs the work of the QO Validation Manager, who leads a team responsible for all product, process, and equipment validation at the site.
Directs the work of the QO Technical Transfer Manager who leads a team responsible for all Quality and Compliance activities performed in support of product transfers.
Directs the work of the QO Validation Laboratory Manager, who leads a number of teams that support the site cleaning validation program, the early stage testing lab, and the method validation lab.
Leads a team of staff, OTE, and front line leaders to ensure that site compliance programs meet defined quality standards and objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Acts as the designated Site Compliance Leader for network-wide compliance initiatives. Fosters teamwork and colleague development, as well as change management, within QO overall. Develops and delivers on key Quality strategies, as a member of the site QO Leadership Team.
Provides guidance and coaching to QO and QC colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and front line managers on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel.
Applies to all QO Managers:
- Understand regulatory requirements and audit strategy
- Review and approve cGMP Documentation to assure compliance with regulatory requirements
- Assess Deviation impacts and resolution
- Review and approve cGMP Changes in accordance with regulatory requirements
- Review and approve training to assure cGMP requirements are met
- Manage Resources to meet organizational goals
- Understand site financial systems
- Understand Safety concerns and maintain safe environment (5S, ergonomics)
- Ability to perform GAP assessments for new &; revised PQS
- Ensure participation in company-wide knowledge exchanges
- Ability to drive change as required by the organization
- Ability to inspire the team or customers to embrace change and motivate them to continuously improve
- Ability to lead Process Improvements using continuous improvement tools
- Ability to communicate processes to internal or external groups to achieve a positive outcome
- Develop, articulate and execute a vision for their team, project or process
This is an onsite position that will be located in San Jose or Emeryville, CA.
Qualifications:
9 - 13 years of experience with BA/BS
8 - 11 years of experience with MBA/MS
6 - 8 years of experience with PhD
8 - 11 years of experience with MBA/MS
6 - 8 years of experience with PhD
Experience: Minimum of 5 years QO management experience in a cGMP environment
Communication: Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
Communication: Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
Reasoning Ability: Strong analytical and problem solving abilities
The annual base salary for this position ranges from $127,400.00 to $212,200.00. In addition, this position offers an annual bonus with a target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.
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.
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