Skip to main content

Search jobs

Search jobs

애브비 정보

애브비의 사명은 현재의 심각한 건강 문제를 해결하고 미래의 의학적 과제를 해결하는 혁신적인 의약품을 발굴하여 세상에 내놓는 것입니다. 당사는 Allergan Aesthetics 포트폴리오 전반에 걸친 제품 및 서비스 외에도 면역학, 종양학, 신경과학, 안과, 바이러스학, 여성 건강 및 위장병학 등 여러 주요 치료 분야에 걸쳐 사람들의 삶에 커다란 영향을 미치기 위해 노력하고 있습니다. 애브비에 대한 더 자세한 정보는 www.abbvie.com을 확인해주십시오. @abbvie 를 Twitter, Facebook, Instagram, YouTube, LinkedIn에서 팔로우하십시오.

Senior Manager, QC CMC

우스터, 매사추세츠 주 공고 ID 2203370 분류 Quality Assurance 분야 AbbVie

Description

The Senior Manager, Quality provides leadership and direction to the Quality Function they are responsible for within Operations. This Sr. Manager role is responsible for the effective implementation of AbbVie Quality Systems for which they are responsible for. This could include QC-CMC, Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality and strategic initiatives. The Sr. Manager of Quality would be expected to manage a budget and leads a team of quality professionals who are responsible for regulatory submission authoring, compliance and quality oversight for the plant and/or strategic initiatives. Expectations that the professional will maintain high quality levels on all products while achieving high efficiency.

Responsibility:

  • Prepare QC related submission sections for IND and BLA submission. Overy see timely availability data and influence cross function team to acquire required data for submissions.
  • Oversee stability and reference standard programs for clinical and commercials project. Analyze release and stability data to establish specifications and shelf life. Author protocols, specification justifications, stability assessment reports, change controls and other quality documents.
  • Represents site and participates in meetings with CMC, global regulatory team and clients for clinical and commercial regulatory submissions relates strategic planning. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Responsible for various aspects of quality control and quality assurance related to products produced at the plant. This will be at a large plant with high volume, high level of product complexity including multiple products at the site and have the complexity of multiple types of production and testing (Biologics intermediates, drug substances, drug products etc)
  • Represents the decision-making authority on job specific aspects of the Quality and Regulatory compliance program for the site.
  • Provides regulatory and technical guidance to all departments in the plant and can be the SME for all AbbVie plants. Communicates with executive level for Quality Management Review, Quality Initiatives, etc.
  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus. Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
Qualifications:

Qualifications 

  • Minimum Bachelor’s Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering; Master’s Degree or PhD preferred.
  • Certified Quality Engineer or formal training in quality engineering or statistics is preferred
  • 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry
  • 4+ years of supervisory/technical leadership experience
  • Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
  • Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
  • Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
  • Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
  • Strong communication Skills, both oral and written
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

최신 채용 공고

가입하여 채용 알림 받기

인재 네트워크에 가임하여 AbbVie 소식과 채용 알림을 받아보십시오.

관심 분야카테고리와 지역 옵션을 선택하십시오. “추가”를 클릭하여 채용 알림을 생성하십시오.

  • Quality Assurance, 우스터, 매사추세츠 주, 미국제거

개인정보 수집, 이용 및 정보주체의 권리에 관한 내용을 알아보시려면 당사 이용약관, 쿠키 정책, 개인정보정책을 확인하십시오. 해당 정보를 제출하면 해당 문서를 읽었으며 애브비로부터 SMS 및 이메일 채용 알림을 받는 데 동의한 것으로 간주됩니다.

최근 살펴본 채용 공고

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Click here to find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application