Use Your Power for Purpose

Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture which is both science and risk-based is designed to be flexible innovative and customer-oriented. Whether your role involves development maintenance compliance or analysis through research programs your contribution is crucial and will have a direct impact on patients.

What You Will Achieve

In this role you will:

• Manage Data Integrity metrics for Department SQRT and Site

• Perform SME impact assessments for Data Integrity in change control records

• Review and approve Data Integrity function activities. (Ex. Audit trail changes Alarm Management changes Data Backup and Archival)

• Own Data Integrity compliance actions

• Assist in audit preparation and join audit team as needed

• Write and approve procedures forms instructional material and job aids.

• Track Data Integrity non-conformances

• Facilitate Data Integrity training as needed

• Facilitate/Assist with ERES SLIA ALCOA assessments and DI assessments

• Participate in global Data Integrity Community of Practice

• Share best practices with site and influence site stakeholders

Here Is What You Need

(Minimum Requirements)

• Applicant must have a bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience;
  OR an associates degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience

• Strong Data Integrity knowledge and ability to apply ALCOA principles in the pharmaceutical industry

• Knowledge of manufacturing computerized systems industry standards and best practices for computer systems.

• Understanding of automation activities and how data integrity principles are applied

• Self-motivated and able to develop work relationships in cross-functional teams.

• Excellent in communication and project management

• Strong interpersonal and influential skills

• Decision-making skills based on a risk science-based approach

• Ability to manage multiple activities and adapt to changing priorities.

• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.

• Excellent organization and follow-up skills.

• Excellent communication skills oral and written and attention to detail.

• Mastery of core computer software/systems (Word Excel PowerPoint etc.).

Bonus Points If You Have

(Preferred Requirements)

• Advanced degree in pharmaceutical sciences or related field

• Thorough understanding of computer system validation and qualification.

• Project Management Experience

• Understanding of sterile product manufacturing.

• Pfizer Human Factors Program (PHP) Practitioner

• Experience with Quality Risk Management (QRM)

• M1 (yellow belt certified) M2 (green belt) qualified

• Experience with eQMS (Veeva Vault) or gQTS (TrackWise)

PHYSICAL/MENTAL REQUIREMENTS

• Mathematical calculation and complex data analysis ability.

• Occasionally lift a computer system and/or instrument up to 50 pounds.

• Use a computer terminal for up to 8 hours per shift work around moving equipment.

• Stand for up to 8 hours sit for up to 8 hours walking climbing stairs responding to visual warning indicators respond to audible warning indicators respond to color or special visual indicators wear specialized protective.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Primary work schedule is day shift Monday Friday but evenings weekends and holidays will be required as needed to support manufacturing processes at the Rocky Mount site.

• Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.

• Minimal travel may be required.

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.