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Principal Senior Project Manager Combination Products Medical Devices all genders 24 months temporary full-time

AbbVieLudwigshafen am Rhein, Rhineland-Palatinate, Germany

Vor 13 Tagen

Stellenbeschreibung

The job that makes possibilities real in patients lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48000 employees worldwide and around 3000 employees in Germany you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care Do you want to contribute to improving patients quality of life through your expertise In a challenging work environment that offers opportunities of developing and increasing your own skills Youve come to the right place!

Moving mountains together as Principal / Senior / Project Manager Combination Products & Medical Devices (all genders) 24 months temporary / fulltime)

Responsibilities

Represents CDSM activities as a member of the Combination Products and Medical Device CMC and Development Teams. Provides input to CMC and Development Teams to influence Design History File content to ensure most efficient utilization of submission resources.
Translates Design History File content into assembly labelling packaging and distribution design. Identifies develops communicates and tracks project timelines activities logistics and milestones. Authors process FMEA specifications and assembly instructions together with stakeholders.
Establishes capabilities and fosters automation progress related to the assembly of Combination Products and Medical Devices together with CPD PDS&T Engineering Department and CSP.
Tracks capital investment equipment projects from purchase to beneficial use
Responsible together with Combination Products Development (CPD) Product Development Science & Technology (PDS&T) and / or Allergan Aesthetics with QA and CDSM functions to establish specifications and instructions to assemble label and pack Combination Products and Medical Devices for submissionrelevant nonclinical and / or clinical use. Manages inventory and plans global shipments of Subparts assembled Combination Products and Medical Devices
Responsible for creating appropriate assembly labeling and packaging work orders in concert with QA Analytical Third Party and partners with CPD and PDS&T to ensure timely availability of supplies.
Responsible for manufacturing of Combination Products and Medical Devices inhouse or by Third Party Manufacturers for Research and Development. Tracks and evaluates manufacturing data from request to release. Trains all pharmacy operational personnel.
Leads troubleshooting and resolves all operational and machinerelated issues ensuring that project needs and priorities are understood by team members. Coaches and mentors staff members on supply requirements and topics. Provides input and recommendation to DSMs Technical Leads and CMC Product Development Directors on project timing and resource requirements.
Must be SME in multiple aspects of Combination Products and Medical Devices topics e.g. Development of Secondary Packaging Materials Compliance of Label Content with global regulations (e.g. CTR MDR CFR) Center of technical Competence related to assembly steps
Successfully leads and participates in within function and cross functional process improvement initiatives.
Maintains and adheres to applicable Corporate and Divisional Policies and procedures.
Responsible and accountable for resolving of all potentially CDSM related issues about product transfer from development to Clinical and / or Commercial Manufacturing together with CDSM QA CPD PDS&T Allergan Aesthetics Operations Third Party Manufacturing Group. Most Senior CSPM within CSM.

Qualifications :

In this department there are various types of Project Manager Combination Products & Medical Devices; these are classified according to the experience and qualifications brought along. The responsibilities listed above will also be adjusted in relation to the level of experience gained.

Project Manager : Bachelors Degree or equivalent education preferably in medical engineering or pharmacy and typically 5 years of experience; or Masters Degree or equivalent education and typically 2 years of experience; or PhD (no additional experience).

Senior Project Manager : Bachelors Degree or equivalent education preferably in medical engineering or pharmacy and typically 7 years of experience; or Masters Degree or equivalent education and typically 5 years of experience; or PhD and typically 2 years of experience.

Principal Project Manager : Bachelors Degree or equivalent education preferably in medical engineering or pharmacy and typically 12 years of experience; or Masters Degree or equivalent education and typically 10 years of experience; or PhD and typically 4 years of experience.

Must have experience in one of the following areas : Drug Discovery (e.g. Process Chemistry Analytical Chemistry) Drug Development (e.g. formulation) Combination Product or Medical Device Development Supply Chain (e.g. Clinical Supplies Project Management) Quality Assurance

Passionate about machines and technology and excellent skills related to engineering machine design and maintenance understanding and automation technology.

Extensive knowledge of global requirements on Combination Products and Medical Devices for use in clinical trials

High degree of flexibility and a strong attitude for identifying innovative approaches in decisionmaking and problem solving. Must be able to proactively and effectively recognize quantify and mitigate potential risks. Proven leadership skills in the management of complex projects.

Ability to think in multiple dimensions and balance many priorities under tight deadlines and high pressure to ensure that samples are manufactured within optimal timing on budget and are of the highest quality while ensuring adherence to applicable regulatory requirements.

Effective communication skills.

Native speaker in German. Fluent in English.

Heres how we can move mountains together

with a diverse work environment where you can have a real impact

with an open corporate culture

with an attractive salary

with an intensive onboarding process with a mentor at your side

with flexible work models for a healthy worklife balance

with a corporate health management that offers comprehensive health and exercise programs

with company social benefits

with a wide range of career opportunities in an international organization

with toptier attractive development opportunities

with a strong international network

Multiple times we have been globally recognized as a Great Place to Work and we are proud to provide our employees with the flexibility to maintain a healthy worklife balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality equity diversity and inclusion (EED&I) a commitment that is fundamental to us. This includes appreciating different perspectives creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie your individual contributions count help us move mountains together. Be a part of our success grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you We look forward to receiving your application! All you need is a complete CV we will discuss everything else with you in person.

Have questions Email we look forward to hearing from you!

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

Employment Type :

Fulltime

Key Skills

Abinitio,Administration And Accounting,Android,Bid Management,Inventory Management,Embedded C

Experience : years

Vacancy : 1

Jobalert für diese Suche erstellen

Senior Project Manager • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany