Specialist III, QA Compliance - Internal Audit & Self Inspection

Location
Morris Plains, NJ, United States
Posted
Jun 06, 2021
Ref
2249325
Required Education
Bachelors Degree
Position Type
Full time
Specialist III, QA Compliance - Internal Audit & Self Inspection
United States - New Jersey - Morris Plains

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Specialist III, QA Compliance - Internal Audit & Self Inspection

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role and Responsibilities:

The Specialist III, QA Compliance will play a critical role in ensuring a continuous and sustainable state of GMP compliance, through internal audit, monitoring, and oversight of self-inspection programs. This position will assist in ensuring all GMP personnel remain compliant with applicable regulatory requirements and Gilead policies and procedures, in support of Gilead clinical/commercial products. This includes ensuring there is appropriate training and consistent data integrity and compliance.

The QA Compliance Specialist III works with the departments across the Gilead NJ site to ensure a state of Inspection readiness and participates in Corporate and Regulatory Inspections. The QA Compliance Specialist III will oversee Quality Risk Management and, as needed, lead cross-functional teams to execute Risk Assessments under the Gilead NJ Quality Risk Management program.

Essential Duties and Job Functions:
  • Lead Internal Audits, as outlined in the yearly audit plan, escalating compliance concerns to Sr. Management as necessary.
  • Ensure timely and effective implementation of CAPAs, mitigation/remediation plan(s) and ensure a continuous state of inspection readiness.
  • Track and trend Self Inspection, Internal Audit, and Regulatory observations and responses to successful closure.
  • Prepare and provide on-site support to Gilead NJ site for regulatory inspections, corporate, and third-party audits. Provide front and back room support. Manage the logistics for the regulatory and third-party inspections.
  • Facilitates transparency and communication of lessons learned and best practice sharing across the organization.
  • Manage the Gilead NJ Quality Risk Management process; Leads cross-functional teams, as necessary, to execute Risk Assessments.
  • Oversees the self-inspection program and develops tools to continuously improve and maintain an effective program.
  • Perform compliance investigations as needed, provide support and review complex investigation reports of non-compliances in GMP areas.
  • Conduct and support pre-approval / pre-submission project reviews, mock inspections, and inspection readiness assessments.
  • Ensure Good Documentation Practices (ALCOA) are followed, through regular compliance oversight of documentation and data.
  • Create, review and/or approve appropriate policies, directives and procedures in alignment with relevant governmental regulations/guidelines and Gilead quality standards.
  • Perform other related tasks and assignments as needed and specified by management related to document generation and control.


Knowledge, Experience and Skills:
  • Technical knowledge of Manufacturing, Facilities, Equipment, and/or Laboratory procedures/processes in the Biologics space is preferred.
  • GMP Audit experience (execution of audits or support role in regulatory inspections) preferred.
  • Take a proactive approach to continuous improvement based on data, trends and outcomes of management reviews.
  • Excellent written and verbal communication skills required, including responsible business communication.
  • Comfortable with ambiguity and can adapt style and tactics based on situation.
  • Focus on achieving objectives within specified timeframe and to meet quality expectations.
  • Knowledge of relevant GMP regulations and guidance to include but not limited to 21 CFR, ICH, EU GDP/GMP, PIC/S.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with all MS Office applications.
  • Ability to work independently and to make decisions based on experience.
  • Preferred degree in a Technical/Science related field (e.g. Biochemistry, Engineering, Chemistry, Biology, etc.) or equivalent.


Basic Qualifications:

6+ years of relevant experience in the pharmaceutical industry and a BS or BA degree.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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