What are the responsibilities and job description for the Aseptic Product Quality Manager position at BioSpace?
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
The Aseptic Product Quality Manager acts as aqualitySME for asepticmanufacturingwithin theExternal Product Quality Assurance Eye CareGlobal Team.The positionis responsible forsupporting aseptic events within theEye Care Quality Assurance Third Party Manufactures (TPM)teamby providing hands-on assessments and investigation support. TheGlobal Quality Managerwill driveimplementationand aseptic best practices at TPM based onAbbVies standardsand technological advancements.
TheGlobal Quality Managerwill work effectively with TPM by promoting improvements that proactivelyidentify, quantify, prioritize,and mitigateaseptic risks.Global Quality ManagerwillalsoestablishcollaborativerelationshipswithAbbVie'sinternalsites, aseptic global team, andcross functional teams.
Maintainsthe primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
Provides Eye Care Quality Assurance Third Party Manufactures (TPM)teamsupport for investigation for aseptic events by providing hands-on assessments and investigation support.
Drivesimplementation and aseptic best practices at TPM based onAbbVies standardsand technological advancements.
Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium andhigh riskevents to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helpsfacilitateresolution in cases where they are not.
Establishesand maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups tomaintainroles and responsibilities,identifypotential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at eachsiteand provide guidance on quality concerns.
Communicates and negotiates with external companies quality organization tomaintaina consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost ofoperatingto provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines,resourcesand conflicting priorities.
Interfaces with Quality Assuranceauditteam to develop audit plans, due diligence plans, and inspection readiness plans, review auditobservationsand responses, andmaintaincorrective action timetable. Provides support for quality audits, initial siteapprovalsand due diligence activities. Leads and manages pre-approvalinspectionreadiness as related to thethird partymanufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
Contributes to Quality Assurance elements needed tofacilitatenew product launches including Third PartyManufacturersthat provide products directly to distribution centers, or to AbbVie domestic andInternationalplants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management ofexceptiondocuments and Corrective and Preventive Actions.
Completes management reviews with assigned Third Party Manufacturers thatidentifyand address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from theThird PartyManufacturer to ensure accuracy, completeness, timeliness, and trends areidentifiedand addressed in an appropriate manner.
Qualifications
Bachelors Degree in relevant Life Science or other technical discipline or equivalent job experiencerequired.
7 years of total combined experience.At least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development or Consulting.
Knowledge and comprehensive understanding of aseptic manufacturing and some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps,extended releaseproducts, coating solutions, and/or active pharmaceutical ingredients).
Possessesknowledge and a skill set tooperatewithin an environment that requires a high degree of urgency, strong analytical andproblem solvingskills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders,membersand individuals.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
The Aseptic Product Quality Manager acts as aqualitySME for asepticmanufacturingwithin theExternal Product Quality Assurance Eye CareGlobal Team.The positionis responsible forsupporting aseptic events within theEye Care Quality Assurance Third Party Manufactures (TPM)teamby providing hands-on assessments and investigation support. TheGlobal Quality Managerwill driveimplementationand aseptic best practices at TPM based onAbbVies standardsand technological advancements.
TheGlobal Quality Managerwill work effectively with TPM by promoting improvements that proactivelyidentify, quantify, prioritize,and mitigateaseptic risks.Global Quality ManagerwillalsoestablishcollaborativerelationshipswithAbbVie'sinternalsites, aseptic global team, andcross functional teams.
Maintainsthe primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
Provides Eye Care Quality Assurance Third Party Manufactures (TPM)teamsupport for investigation for aseptic events by providing hands-on assessments and investigation support.
Drivesimplementation and aseptic best practices at TPM based onAbbVies standardsand technological advancements.
Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium andhigh riskevents to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helpsfacilitateresolution in cases where they are not.
Establishesand maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups tomaintainroles and responsibilities,identifypotential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at eachsiteand provide guidance on quality concerns.
Communicates and negotiates with external companies quality organization tomaintaina consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost ofoperatingto provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines,resourcesand conflicting priorities.
Interfaces with Quality Assuranceauditteam to develop audit plans, due diligence plans, and inspection readiness plans, review auditobservationsand responses, andmaintaincorrective action timetable. Provides support for quality audits, initial siteapprovalsand due diligence activities. Leads and manages pre-approvalinspectionreadiness as related to thethird partymanufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
Contributes to Quality Assurance elements needed tofacilitatenew product launches including Third PartyManufacturersthat provide products directly to distribution centers, or to AbbVie domestic andInternationalplants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management ofexceptiondocuments and Corrective and Preventive Actions.
Completes management reviews with assigned Third Party Manufacturers thatidentifyand address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from theThird PartyManufacturer to ensure accuracy, completeness, timeliness, and trends areidentifiedand addressed in an appropriate manner.
Qualifications
Bachelors Degree in relevant Life Science or other technical discipline or equivalent job experiencerequired.
7 years of total combined experience.At least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development or Consulting.
Knowledge and comprehensive understanding of aseptic manufacturing and some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps,extended releaseproducts, coating solutions, and/or active pharmaceutical ingredients).
Possessesknowledge and a skill set tooperatewithin an environment that requires a high degree of urgency, strong analytical andproblem solvingskills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders,membersand individuals.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html