Device Quality - QMS Lead, Combination Products

Employer: Bristol Myers Squibb Company
Location: New Brunswick, NJ, US
Start date: Dec 13, 2018

Discipline: Marketing, Product Development/Management, Quality
Required Education: Bachelors Degree
Position Type: Full time
Hotbed: Pharm Country, Best Places to Work

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Job Details
Company

Job Details

The Device Quality - QMS Lead, Combination Products has job responsibilities that include but are not limited to:

Ensure compliance to cGMP, 21 CFR Part 4, BMS standards and other global health authority requirments for medical devices/combination products.
Assist with periodic audits of device component suppliers, external design houses, service providers, and contract manufacturers and distribution centers
Author or coordinate the writing of comprehensive quality system documents. Initiate, update, review, or assist in the drafting of the quality manual, policies, directives, standard operating procedures and work instructions.
Ensure that new medical device/drug combination products follow the appropriate design control process consistent with health authority regulations/expectations.
Ensure risk management is executed through Risk Management Plans, Risk Files, Hazard analyses, and risk analyses eg dFMEA, pFMEA, uFMEA etc. throughout the life cycle of the product.
Provide consultation and training on combination products and medical devices to internal and cross-functional groups
Lead Quality System improvement initiatives
Support the device quality councils/mangement reviews by generating relevant data to be presented to management regarding the status of the Device QMS
Participate in teams to generate, update or assist in the drafting of policies, procedures, and work instructions related to product quality metrics (eg, risk assessment for product quality complaints, product quality complaint surveillance thresholds, etc).
Serve as SME for evaluating the impact and applicability of new device/combination product regulations via the PEARLprocess.

Education:

The position requires a minimum of a Bachelor of Science degree. A life science degree is preferred, e.g., Pharmacy, Chemistry, Biology, Engineering.

Experience/Knowledge:

Direct Quality unit responsibility for the development and commercialization of medical device/drug or biologic combination products.
Minimum of 8 years experience in medical device/drug combination product development and manufacturing role, in a Quality, Technical, or Regulatory position or a combination thereof.
Direct experience in supporting commercial manufacturing sites and HQ groups through global health authority inspections.
Expert in Quality System Regulation, Part 4, Combination Product Guidance and cGMP.
Demonstrated experience leading and contributing through influence and working in cross functional teams to investigate and manage quality and compliance related issues.
Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
Knowledge in combination product design, development, and manufacturing, Quality Assurance, Validation, Technology Transfer, Supply Chain, Packaging, Surety, and Logistics.
Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
In-depth knowledge of quality systems principles and applications.
Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
Excellent oral and written communication skills.
Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
Pragmatic in approach with demonstrated ability to make sound, risk-based decisions
Mastery of Quality processes and regulations, e.g., GMP regulations. A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality and complaint investigations.
A minimum of 2 years of CGMP/QSR auditing experience, preferably certified device auditor (e.g., ISO RAB, etc).
In depth knowledge of product attributes as they relate to regulations..
A minimum of 7-10 years of experience in Quality Operation

Skills/Competencies:

Knowledge of effective styles of communication, change management, and leadership.
Ability to analyze and solve complex problems.
Ability to work independently and use initiative.
Ability to prioritize work and rapidly change priorities when necessary.
Ability to develop win/win solutions.
Ability to effectively manage difficult people and situations

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

Company info

Website: http://www.bms.com/
Phone: +1-800-332-2056
Location: 430 E. 29th St
14th Floor
New York
New York
10016
United States

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