Sr. Quality Assurance Specialist

Gilead Sciences Inc.; Maryland; On-site; USD 124,000 - 160,000; Full time

Job summary

Gilead Sciences Inc. seeks a Senior Quality Assurance Specialist to lead batch record review and release, ensure GMP compliance, and support continuous improvement across manufacturing and quality control data.

You will collaborate with regulatory affairs, internal partners, and external bodies, perform risk assessments, and participate in deviations, CAPAs, and change control to ensure product quality and patient safety.

Qualifications

• Bachelor's degree with 6+ years of experience or
• Master's degree with 4+ years of experience or
• PhD/PharmD with 0+ years of experience.
• Experience with parenteral and aseptic operations; familiarity with Annex 1 requirements.
• Experience across broad QA and/or Quality Systems.
• Experience with interacting with regulatory agencies.

Responsibilities

• Lead batch record review and release activities across manufacturing and QC data.
• Participate in risk assessments and changes to SOPs and controlled documents.
• Support site inspection readiness and internal/external audits.

Skills

Communication skills

Regulatory interaction

Quality mindset

Education

Bachelor's degree

Master's degree

PhD or PharmD

Tools

HACCP

FMEA

Job description

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Quality Assurance Specialist at Gilead you will have the following responsibilities:

• Manages, prioritizes, and participates in batch record review and release activities, including review of manufacturing, environmental monitoring, and quality control data for in-process and finished products. Responsible for final release of manufactured products.
• Participates in introduction of new clinical/commercial products (e.g., small molecules and biologics) to the site.
• Participates in risk assessments.
• Participates in author, review, and approval of changes to standard operating procedures, specifications, forms, and other controlled documents to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• Participates in site inspection readiness activities.
• Participates in internal and external audits as needed.
• Participates in continuous improvement initiatives.
• Supports generation, and review of metrics and trending data.
• Partner with internal partners to ensure resolution of quality issues.
• Participates in review/approval of Deviations, CAPAs, and Change Management records as required.
• Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgement is required in resolving problems and making scientific routine recommendations.
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

Requirements

• Bachelors Degree and 6+ years of experience required OR
• Masters Degree and 4+ years of experience required OR
• PhD or PharmD with 0+ years of experience
• Experience with parenteral and aseptic operations; proficiency or familiarity with Annex 1 requirements.
• Experience across broad areas of Quality Assurance and/or Quality Systems.
• Experience with interacting with regulatory agencies.
• Excellent interpersonal, verbal, and written communication skills.
• Knowledge of Risk Management tools (e.g., HACCP and FMEA)

Preferred Qualifications

• Advanced degree (Masters or PhD/PharmD) is preferred
• Experience with batch record review and release of clinical and/or commercial product preferred
• Experience with medical devices preferred
• Experience with biological products

People Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $123,930.00 - $160,380.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the "Know Your Rights" poster.

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

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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: