Sr Quality Systems Engineer

Biopharma Careers; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

401(k) Plan

Paid Time Off

Life Insurance

Job summary

Teva Pharmaceuticals USA is seeking a senior Quality Assurance professional to lead GMP-compliant QA activities in Salt Lake City. You will drive quality systems, manage change control, and ensure readiness for regulatory inspections.

The role requires a bachelor’s in a scientific field and 7+ years in pharma, with 3+ years in QA and experience with FDA/EMA inspections preferred.

Qualifications

• Bachelor’s degree in scientific discipline or equivalent with 7+ years in pharma.
• Minimum 3 years of Quality Assurance within pharmaceutical production.
• Prefer direct Health Authority inspections experience (FDA/EMA/ANVISA).

Responsibilities

• Develops and executes projects delivering site metrics and quality program goals.
• Hosts Change Control Review Board and oversees change control activities.
• Provides records management and change control support for compliant shutdowns.
• Ensures operations comply with CGMP, FDA, EMA and SOP requirements.
• Participates in internal, partner and regulatory inspections and audits.
• Reviews and approves SOPs, protocols and risk assessments; maintains quality records.

Skills

Quality Assurance

GMP

FDA

Regulatory inspections

Project management

Presentation skills

MS Office

Education

Bachelor’s Degree in science (biology, chemistry) or related field

Tools

Trackwise

Veeva

Job description

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

Location: SLC EAST

577 S. Chipeta Way

Salt Lake City, UT 84108

How You’ll Spend Your Day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.
• Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.
• Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.
• Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.
• Responsible for participating in partner, internal and regulatory inspections and audits as needed.
• Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.
• Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.
• Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP).
• Responsible for performing additional related duties as assigned.

Your Skills and Experience

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

Bachelor’s Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.

Requires a minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.

Prefer direct experience with the manufacturing of various pharmaceutical dosage forms.

Prefer direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)

Project management and advanced presentation skills preferred

Also Good to Have

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as Quality systems such as Trackwise and Veeva.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Ability to demonstrate sound judgment and decision making.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and external partners.
• Ability to analyze information and create metrics relevant to the business objectives.
• Ability to understand inter-department linkages and alignment of own department with other departments.
• Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct method and procedure for problem resolution.

PHYSICAL REQUIREMENTS:

Frequent:

• Sitting for extended periods of time.
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.

Occasional:

• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:

• Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading.

WORKING ENVIRONMENT:

• Frequent exposure to low to moderate noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, hearing protection, gloves, etc.).

How We’ll Take Care of You

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holiday.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to [e-mail] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.

Important notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.