Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords

Director, Sterile Injectables & Biotech Quality Ops Compliance

Company

Pfizer
Address , Pearl River, Ny
Employment type FULL_TIME
Salary
Expires 2023-10-02
Posted at 9 months ago
Job Description
This role will drive compliance and performance excellence across the cluster sites. The role will provide technical expertise, drive compliance initiatives, inspection readiness as well as continuous improvement projects. The role will work closely with the QO Cluster lead on BOH notifications, BOH responses, AQRT’s etc
This position will work closely across the Sterile Injectables and Biotech Operating Unit (SBO).It will liase with the QO Cluster Leads as well as other Compliance leads to drive vertical and horizontal integration.
POSITION RESPONSIBILITIES
General Scope of Responsibilities:
  • Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness. Provide technical SME support and BOH response writing/review
  • Lead successful and timely execution of quality and compliance improvement initiatives.
  • Member of the SBO QO Cluster Leadership team.
  • Provide technical inputs to evaluate investigations, and product and process issues, including the ability to identify root cause and corrective and preventative actions, and accountable to provide leadership to drive issues to timely resolution.
  • Prepare and facilitate Cluster/OpU Quality Review meetings.
  • Provide rapid and effective cross-site coordination of significant investigation activities associated with sterile products.
  • Work in coordination with the QO Cluster Leads and QPL to drive the site regulatory strategy for key products, site digital strategy and continuous improvement initiatives.
  • Review and approval of significant investigations, AQRT summaries, BPDR/FAR and other technical documents as required
  • Provide quality decision making along with the QO Cluster lead
  • Conduct data analytics/review to enable proactive detection of quality and compliance signals and trends. Drive remediation plans based on the signals and trends.
ORGANIZATIONAL RELATIONSHIPS
  • The role routinely interacts with the following roles: Quality Operations SBO Cluster Leader, Regional Quality Operations Leaders, Quality Product Leads, Site Quality Operations Leaders, Operations Leadership, Site Leaders, Site Quality Compliance Leaders, and Center Quality Leadership.
RESOURCES MANAGED
Financial Accountability
  • The role does not have any budget oversight. The role will provide support to the site budget processes.
Supervision
  • There are no direct reports for this position. The position has matrix responsibility for ensuring the success of the sites and other functional managers.
EDUCATION AND EXPERIENCE
Education:
  • Minimum B.S. in any engineering, science or related discipline.
Experience:
  • Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority.
  • Minimum 10 years QA related experience is necessary and 5 years of robust site Quality management experience (preferred)
  • Demonstrated skills in analyzing, organizing, and project management with a high sense of urgency.
  • 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.
  • Demonstrated change agility to successfully manage a high degree of complexity and priorities.
  • Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.
TECHNICAL SKILLS REQUIREMENTS
  • Proven analytical skills capable of evaluating complex data to identify trends and signals.
  • Leadership and management of projects that require collaborative approaches, strong analytical skills, and a solid ability to understand business issues and processes.
  • Strong knowledge of global cGMP quality and compliance requirements.
  • Must be fluent in English.
  • Excellent interpersonal and leadership skills including a demonstrated ability to positively influence and coach others, participate in teams at all levels of management and achieve results through others.
PHYSICAL POSITION REQUIREMENTS
  • Based on the global nature of this role travel is required (up to 30%).
ADDITIONAL POSITION DETAILS
  • Position can be remote based

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.
Work Location Assignment: Remote

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.
Quality Assurance and Control
#LI-PFE