Quality Director, Env Ctrl & Aseptic Compliance
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Job Location:
Rocky Mount, NC - USA
Monthly Salary:
$ 156600 - 261000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
The Quality Director Env Ctrl & Aseptic Compliance is responsible for environmental monitoring contamination control microbiology lab method compliance media fill unit evaluation manufacturing aseptic oversight product tests are meeting internal and external quality and regulatory standards and GMP compliance documentation. The Director has oversight of the site Contamination Control Program EM Laboratory and EM investigations.
This position will be a member of the Site Quality leadership Team (QLT) and will report to the Site Quality Operations Leader (SQOL).
What You Will Achieve
- Responsible for providing leadership strategic direction and oversight for the different teams
- Responsible for staffing training & development motivation & coaching giving feedback and effective listening & communication towards his/her colleagues.
- Responsible for the environment and the health and safety of the team.
- Plan departmental objectives in support of the site and the PGS objectives
- Ensure that tests are performed according to company and legal standards and methods and are in full compliance with cGMPs.
- Stay current of internal and external requirements and regulations and keep focus on best practices
- Manage department at optimal overall cost
- Provide lab support for site projects and registration
- To promote and ensure a high level of GMP awareness and culture in the labs
- Ensure that all personnel are adequately trained and developed as needed
- Foster an environment of continuous improvement and learning in Quality GMP equipment methods processes
- Drive / support operational excellence through:
- Data driven analysis
- Compliant effective and efficient systems
- Continuous improvement principles and tools
- Use of standard work processes
- Effective teamwork and organization in general
- Trend analysis of deviations and defining /follow up of preventive actions
- Provide vision to support process owners
- Ensure individual and team training is up to date relative to the duties being performed.
- Responsible for staff development of direct reports and others.
- Sets expectations for goal setting ongoing assessments and coaching/performance evaluations to motivate direct reports and deliver results for the department and business lines.
- Identify growth and development opportunities for direct reports.
- Respects the PGS vision mission values and leadership behaviors in order to realize the PGS objectives related to quality GMP customer satisfaction right first time and cost.
Here Is What You Need (Minimum Requirements)
- Must have a Bachelors Degree in relevant scientific discipline microbiology chemistry pharmaceutical sciences or engineering with 8 years relevant experience in the pharmaceutical industry
- OR MBA/Masters Degree with 7 years relevant experience in the pharmaceutical industry.
- 5 years of management experience
- Analytical and scientific skills
- Proven problem-solving abilities
- Organizational skills
- Good human interaction and leadership skills with different levels in the organization (negotiating convincing motivating coaching listening learning)
- Good communication skills (oral and written)
- People Leadership (leader of leaders) and talent development experience.
- In-depth knowledge and experience of pharmaceutical cGMP principles and concepts of relevant quality processes based on previous roles.
- Ability to function autonomously in a matrix model and in a team environment.
- Able to communicate complex information in both verbal and written formats.
- Good interpersonal and leadership skills including a demonstrated ability to positively influence and coach others.
- Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
- Sound knowledge of validation principles and methods quality by design.
- Experience with GMP electronic systems and tools
- Ability to work independently as well as in a team environment within own team and interdepartmental/matrixed teams.
- Proactive approach and strong critical thinking skills.
- Effective written and oral communication skills.
- Self-motivated engaged and able to perform moderately complex tasks independently.
- 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.
PHYSICAL/MENTAL REQUIREMENTS
May need to stand for long periods to time
Be able to wear Lab Safety PPE
Be able to gown into Production area
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Be able to work no standard hours and support 24/7 manufacturing operations
Work Location Assignment:On Premise
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 providers 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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Director
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
