דרושים Management Engineer ב-United States, Utah, Salt Lake City

ESSENTIAL AREAS OF RESPONSIBILITY

• Responsible for providing a thorough and timely review/approval or author/execution of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments, and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for leading cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviation from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of critical, complex and/or challenging events as assigned.
• Responsible for serving as QA lead on research and development products and related document reviews/approvals – including change control items, protocols, batch records and deviations as applicable and product disposition.
• Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM.
• Responsible for serving as QA backup for final review/release of production batch records, managing the site change control system and for validation/qualification protocols and related activities.
• Responsible for completing 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’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

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

Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of seven years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Preferred experience in a solid dose manufacturing environment.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with managing partner relationships preferred.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Motivate, influence and lead others with and/or without direct supervisory authority.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.
• Project management and advanced presentation skills preferred.

Problem Solving:
• Proactively works on problems of a moderate to 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 recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
• N/A

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

Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

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 holidays.
• 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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Senior Biosimilar Regional Account Manager is responsible for recruiting, coaching, managing and training Biosimilar regional Account managers (BRAMs).

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.

• The Senior Regional Manager leads a team of BRAMs that are responsible for creating successful partnerships between Teva and identified customers to promote Teva's product portfolio of biosimilar products
• Responsible for contributing to the achievement of TEVA’s overall annual business objectives
• Clarifies and sets team objectives/expectations, formulates and executes a strategy to ensure performance targets are met/exceeded.
• Provides guidance/coaching in the creation and development of account plans, execution of plans through effective coordination, collaboration and communication. Monitors account plans to ensure objectives and performance targets are achieved.
• Coaches BRAMs on understanding external environmental forces, and emerging trends that affect the healthcare, biotechnology industries and Teva’s markets, products, and operations.
• Models behavior that encourages honest, timely, and specific feedback and establishes expectations for others to do the same.
• Provides frequent individual coaching and feedback that empowers the BRAM’s ability to achieve objectives. Utilizes the following tools but not limited to: monthly business plans, annual and semi-annual performance reviews
• Develops and helps Direct Reports achieve their Individual Development Plans
• Recruit, interview, hire, develop and retain top talent.
• Partners and works cross-departmentally with Sales, Marketing, Market Access, National Account Directors, and Regional Account Managers to insure customers are served appropriately, uncovers opportunities for new sales growth, develops strategies to insure customers receive appropriate solutions to their needs with Teva products.
• Anticipates and responds to changing market conditions by:
• Maintaining an awareness of biosimilar marketplace dynamics to provide guidance to direct reports to ensure business strategies are adapted to maximize opportunities and reduce threats
• Having a deep understanding of customers’ needs and expectations
• Implementing forward thinking business strategies

*territory boundaries are subject to change based on business need

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 business or a scientific discipline, MBA preferred
• A minimum of 5 years pharmaceutical/biotechnology sales and/or account management experience
• Demonstrated track record of success, leading teams and developing talent
• Experience in executing and implementing business contracts
• Strategic account management experience in developing and implementing account-specific business plans as well as the ability to coach and support others in doing the same.
• Minimum 2 years of people management experience preferred
• Buy-and-bill experience highly preferred

Skills/Knowledge/Abilities:

• Effective verbal and written communication skills and organizational abilities
• Understanding of financial concepts and contracting issues specific to pharmaceutical distribution
• Understanding of patient drug access, and healthcare provider payment/payer reimbursement
• Understanding of ASP, NCR, and reimbursement dynamics within IDN and clinic spaces.
• Ability to travel within region on a regular basis which will include frequent overnight travel

PHYSICAL REQUIREMENTS:

Occasional:

• Sitting for extended periods of time at work station or mobile equipment.

Visual Acuity:

• Perform activities such as computer work, preparing and analyzing data, and extensive reading.

WORKING ENVIRONMENT

• May be required to wear personal protective equipment (PPE) as needed on site visits (i.e. safety glasses, hearing protection, gloves, etc.).

The annual starting salary for this position is between $148,000 – $194,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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 holidays.
• 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.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.