Product Quality Senior Manager

We need to output HTML fragment with sections: About the role? Actually we have Company Description and Job Description. The instructions: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. Do not put Job ID etc. Preserve ALL substantive information; remove boilerplate, navigation, legal, EEO, equal-opportunity, scam-warning, duplicated lines, application instructions. Include a section ONLY when posting has real, specific content for it — never emit a heading followed by filler/placeholder text. Prefer few substantive sections over many thin ones. We need to decide which sections to include based on content. We have: - Company Description (About AbbVie) – could be "About the role"? Actually "About the role" is typical heading for role description. But we have company description separate. Could we put under "About the role"? The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can map content accordingly. We have: - Job Description: Responsible for quality of assigned products ... (this is role description). Could be under "About the role". - Responsibilities: a long list. - Qualifications: Bachelor’s Degree ... etc. - Additional Information: includes compensation range description, benefits, long-term incentive programs. This could map to Benefits and Pay sections. We have no explicit Skills section separate; qualifications cover skills. Could combine. We have no explicit Schedule info. We have Pay: The Additional Information includes compensation range description but not actual numbers. It says "The compensation range described below is the range of possible base pay compensation..." but they didn't actually give numbers in the text. Actually they didn't provide numbers; they just describe that there is a range. Since we should not create Pay section unless posting actually states them (specific numbers). It does not give numbers, just says range described below but not provided. So we should not include Pay section because no specific numbers. Benefits: They mention "We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs." That's specific benefits. So we can include Benefits section. Schedule: none. Thus sections: About the role, Responsibilities, Qualifications, Benefits. We might also include Requirements? Qualifications already covers. Could we separate Requirements and Qualifications? The posting has "Qualifications" heading with details. Could treat that as Qualifications. Requirements maybe not separate. We need to preserve all substantive information. So we need to include all details from Company Description, Responsibilities, Qualifications, Additional Information (benefits). Also maybe include note about grade commensurate? That's under Responsibilities? Actually "Grade is commensurate on level of overall responsibility." That's a statement about grade; could be included in About the role or Qualifications? It's not a requirement but a note. We'll include it in About the role. We must remove boilerplate: Company Description includes AbbVie mission etc. That's substantive? It's company description; we can keep as part of About the role? The instruction says preserve ALL substantive information; do not invent or summarize away detail. So we need to keep the company description text. Where to place? Could be under About the role as introductory paragraph. We also need to remove duplicated lines, navigation, legal, EEO, equal-opportunity, scam-warning, application instructions. The Additional Information includes a lot of legal text about compensation, benefits, equal opportunity employer, etc. We need to remove EEO/equal-opportunity boilerplate. The Additional Information includes: "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, visit ..." and accommodation links. Those are boilerplate; we should remove them. Also the note about compensation not being wages until earned etc. That's also legal boilerplate; we should remove? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So we should remove legal disclaimers about compensation, etc. However we need to keep substantive benefits info: "We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs." That's substantive. The rest is legal boilerplate; remove. Also the "Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below ..." is legal boilerplate; remove. Thus we keep only the benefits sentence. Now we need to format. Structure:

About the role

Company description paragraph + role description paragraph + grade statement.

Then

Responsibilities

• ... each responsibility as list item.

Then

Qualifications

• ... each qualification as list item.

Then

Benefits

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.

We must ensure we preserve all substantive information from responsibilities and qualifications. Let's extract responsibilities list from the text. Responsibilities paragraph: It's a long sentence with many items separated by periods. We need to split into list items preserving each duty. Original responsibilities text: "Maintains the 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.Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.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 and high risk events 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. Helps facilitate resolution in cases where they are not.Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and International plants 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 of exception documents and Corrective and Preventive Actions.Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner." We need to split each sentence into list items. Ensure we keep the content. Let's list them: 1. Maintains the 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. 2. Primary driver for the quality and compliance aspects of product transfers and organization optimization. 3. Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. 4. Implements agreed strategy. 5. Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers. 6. 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 and high risk events to AbbVie management. 7. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. 8. Helps facilitate resolution in cases where they are not. 9. Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns. 10. Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. 11. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities. 12. Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. 13. Provides support for quality audits, initial site approvals and due diligence activities. 14. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. 15. Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. 16. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). 17. Supports the management of exception documents and Corrective and Preventive Actions. 18. Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. 19. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner. Now Qualifications section: Original qualifications paragraph: "Bachelor’s Degree in relevant Life Science, Engineering, or other technical discipline required. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.Total combined years of experience. Minimum 8+ years. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting. Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred.Knowledge and a comprehensive understanding/expertise of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets