Address
Form of work
SalaryWhy 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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. This is an onsite position that will be located in Rocky Mount NC.
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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. This is an onsite position that will be located in Rocky Mount NC.
What You Will Achieve
Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance required for distribution and the market.
Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance required for distribution and the market.
How You Will Achieve It
As the Disposition Manager QA Operations, you will be responsible for providing Quality Assurance support and leadership for day-to-day operations of Finished Product Dispositions and activities relating to Quality Specialist selection, evaluation, and performance. This position reports to the Sr. Manager of Drug Product QA Operations at the Rocky Mount site. Key accountabilities include management of a team of individual contributors in the support of the finished product dispositions.
As the Disposition Manager QA Operations, you will be responsible for providing Quality Assurance support and leadership for day-to-day operations of Finished Product Dispositions and activities relating to Quality Specialist selection, evaluation, and performance. This position reports to the Sr. Manager of Drug Product QA Operations at the Rocky Mount site. Key accountabilities include management of a team of individual contributors in the support of the finished product dispositions.
The Disposition Manager will also be involved in continuous improvement programs and other projects as required. Disposition Manager is the primary quality contact and ensures quality of finished product through sampling, testing and evaluation of drug products, as well as accuracy and completeness of batch record and audit documentation.
The Disposition Manager for QA Operations is accountable for the strategic planning of workload for the team and ensuring the disposition of product in support of LTA (Lead Time Attainment). This Leader provides core support to the overall compliance and success of QA Operation team.
The candidate must have experience in pharmaceutical industry in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. Working in strong partnership with Production Operations to optimize compliance to RFT (Right First Time).
The job duties include, but are not limited, to the following:
- Manage multiple priorities and effectively communicate priorities to interdepartmental QA Ops team.
- Use critical thinking and problem-solving skills to identify and correct situations which would create delays and/or downtime for batch disposition.
- Act with ownership and make quality decisions.
- Ensures QA Ops team perform quality reviews to ensure accuracy, consistency and completeness of documents deemed for commercial release and where required regulatory submission in accordance cGMP practices.
- Collaborates with document authors and other production operations team members to address and resolve quality observations identified during QA Ops team review.
- Interpret and implement quality assurance standards and procedures.
- Support internal audits and other quality assurance activities.
- Support on-site audits conducted by external providers.
- Analyze data to identify areas for improvement in the QA Operations team.
- Prepare reports to communicate outcomes of quality activities.
- Identify training needs and organize training interventions to meet quality standards for the QA Operations team.
- Assure ongoing compliance with quality and industry regulatory requirements.
- Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes, process improvement initiatives, and strategies.
- Perform other duties as assigned.
Key Competencies:
- Attention to detail.
- Communication skills - verbal and written.
- Data collection, management, and analysis
- Problem analysis and problem solving
- Planning and organizing
- Sound judgement
- Decision-making skills
- Customer service orientation
- Effective interaction with stakeholders
- Teamwork
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience
- OR an Associates degree with 8 years of experience
- OR a Bachelors, health care, scientific or technical degree is preferred, with at least 5 years of experience
- OR Masters Degree with more than 3 years of experience
- OR a PhD with 0+ years of experience.
- Experience in quality control / quality assurance and / or manufacturing / production areas, within the pharmaceutical industry is required.
- Knowledge of global safety regulations and guidelines, or equivalent.
- Demonstrated strength in analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills.
- Demonstrated organizational/project management skills.
- Ability to make decisions independently and problem-solving abilities.
- Demonstrated computer literacy, particularly in the use and management of relational databases.
PHYSICAL/MENTAL REQUIREMENTS
- Due to the size and scale of the facility, substantial walking is required.
- Candidate will be required to gown and execute responsibilities according to area specific procedures.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- The position is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards.
Other Job Details:
- Last date to apply: 3/4/2024
- Relocation support available
- 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 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. This position requires permanent work authorization in the United States.
