Associate Director - Quality Assurance - Device Assembly

We need to output HTML fragment with sections: h3 headings for sections present. Must not repeat job title. Must not include Job ID etc. Must include only sections with real content. Must remove boilerplate like EEO, accommodation request, etc. Must keep substantive info. We need to parse the posting. Key content: - Organization Overview: repeated paragraph about Lilly. Should we include? It's generic but maybe considered boilerplate? It's about company overview. Might be considered not specific to role. The instruction: "Prefer a few substantive sections over many thin ones." Might still include "About the role" or "Position Overview". The posting includes "Position Overview". That's specific. We have sections: Position Overview, Responsibilities, Basic Requirements, Additional Skills/Preferences, Additional Information (flex hours, location, travel, short term assignment). Also Pay (anticipated wage $123,000 - $198,000). Benefits (comprehensive benefit program details). Schedule? Not explicit besides full-time? It says Full-time equivalent employees also will be eligible for a company bonus. Not schedule specifics. Might not create Schedule section unless explicit. We need to use

for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content to these headings. The posting has "Position Overview" (could be About the role). "Responsibilities". "Basic Requirements" (could be Requirements/Qualifications). "Additional Skills/Preferences" (Skills). "Additional Information" (maybe includes location, travel, short term assignment). Pay section: "Actual compensation will depend..." includes wage range. Benefits: description of benefits. We should not include headings with filler. So we will include: About the role (Position Overview), Responsibilities, Requirements (Basic Requirements), Skills (Additional Skills/Preferences), Benefits, Pay. Possibly also "Location" but not a standard heading; we could fold location into Additional Information under maybe "About the role" or separate? The instruction says use those headings only; we can create other headings? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies we should use those headings when appropriate; we could also use other headings? Probably better to stick to those. So we can put location info under "About the role" or maybe under a generic paragraph not a heading. But we need to preserve all substantive info. We could include location in a

under About the role. We must not include boilerplate like EEO, accommodation request, ERGs, etc. Also remove duplicated lines. Let's extract substantive content: Organization Overview: repeated twice; we can include a brief about Lilly? Might be considered boilerplate but it's about the company. Might be okay to include under About the role? But the instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Organization Overview is not exactly those, but it's generic company description. Might be considered boilerplate? Not sure. Safer to include a short paragraph about Lilly under About the role? However the Position Overview already includes specifics about role. The Organization Overview is repetitive; we could omit it as it's not specific to role. The instruction: "Prefer a few substantive sections over many thin ones." So we can skip generic company overview. Thus About the role: we can use Position Overview paragraph(s). Let's capture: "Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Associate Director, Quality Assurance (QA) – Device Assembly (DA), is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device assembly and operations at the Kenosha site. This individual is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda." That's the Position Overview. Responsibilities: list of bullet points (the long paragraph with many responsibilities separated by periods). We need to convert to

• . The responsibilities are a long sentence with many clauses separated by periods. We'll split at each period that ends a responsibility. Let's extract: - Support the Sr. Director, QA, in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in Device Assembly and Packaging (DAP). - Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team. - Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for DAP. - Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for device assembly. - Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group. - Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment. - Engage team and delegate to achieve results through others to deliver according to plan. - Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates. - Demonstrate flexibility with quick response as priorities change or issues arise. - Partner with production and design organization to ensure 24/7 Quality oversight and support. - Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation. - Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, for DA operations. - Network with global and other DA sites to understand best practices, share knowledge. - Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management. - Set area human resource and business plan goals. - Participate in tactical and strategic business planning. - Communicate on project and production status. - Define, lead and/or support inspection readiness activities for operations and interact with Regulatory agencies during inspections. That seems comprehensive. Basic Requirements: list: - Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience. - Minimum 5 years’ experience in pharmaceutical leadership with QA experience, including leading or working effectively with a cross-functional group - Minimum 5 years’ experience directly supporting a pharmaceutical manufacturing operation (preferably device assembly operations) - On-site presence required Additional Skills/Preferences: list many items. We'll convert to
  • . - Strong knowledge of Quality Management Systems and applicable regulatory requirements - Previous regulatory inspection readiness and inspection execution experience - Previous facility or area start up experience - Previous equipment qualification and process validation experience - Previous experience with SAP or other inventory management systems - Previous experience with highly automated combination products, packaging, and warehouse operations - Previous experience with Manufacturing Execution Systems and electronic batch release - Previous experience with automated material movement (central palletizing operation, automated warehousing) - Previous experience with deviation and change management systems such as Veeva - Excellent interpersonal, written and oral communication skills - Strong technical aptitude and ability to train and mentor others - Demonstrated technical writing skills - Demonstrated problem-solving and decision-making skills Additional Information: includes: - Flex hours possible - Primary location is Kenosha, Wisconsin - Ability to travel (approximately 10-20 %) - Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role We could put these under a section maybe "Additional Information" but not a standard heading. Could incorporate into About the role or maybe under "Schedule"? Not exactly. Could create a heading "Details" but instruction says use those headings; but we could still use

    for a custom heading? It says use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). The e.g. suggests those are examples, not exclusive. Safer to stick to those. We could put location, flex hours, travel, short term assignment under "About the role" as a paragraph. Pay: we have wage range and bonus eligibility. Also mention Full-time equivalent employees also will be eligible for a company bonus. So Pay section: include wage range and bonus. Benefits: comprehensive benefit program description. We'll include that. We must not include boilerplate like EEO, accommodation request, ERGs, etc. Also remove duplicated lines (organization overview duplicated). Also remove application instructions (none). Also remove lines about job description may change, etc. That's generic but maybe not boilerplate? It's a disclaimer about job description changes. Might be considered boilerplate; better to remove. Also remove lines about Lilly reserves right to amend compensation etc. That's also boilerplate. Thus final HTML:

    About the role

    Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Associate Director, Quality Assurance (QA) – Device Assembly (DA), is responsible for staffing, training, and leadership of the quality assurance group supporting the start-up of combination product device assembly and operations at the Kenosha site. This individual is responsible for quality oversight of process development, operational readiness, qualification, and validation of the facility and its associated equipment. The Associate Director will help build a strong quality culture at the site and lead the QA team ensuring robust oversight and support of the ongoing operation as well as the site inspection readiness agenda. Flex hours possible. Primary location is Kenosha, Wisconsin. Ability to travel (approximately 10-20%). Ability for Short Term Assignment (6-9 Months) in a Device Assembly and Packaging site prior to starting the role.

    Responsibilities

    • Support the Sr. Director, QA, in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in Device Assembly and Packaging (DAP).
    • Support the site to ensure a safe work environment including supporting and leading safety efforts for the quality team.
    • Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for DAP.
    • Build a diverse and capable site organization to provide quality oversight and ensure compliance with area procedures and controls for device assembly.
    • Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
    • Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
    • Engage team and delegate to achieve results through others to deliver according to plan.
    • Manage multiple priorities in a fast-paced environment and deliver in accordance with established due dates.
    • Demonstrate flexibility with quick response as priorities change or issues arise.
    • Partner with production and design organization to ensure 24/7 Quality oversight and support.
    • Engage and support Operational Excellence initiatives for monitoring performance and continuously improving the operation.
    • Review and approve GMP documentation including qualification/validation protocols and reports, procedures, deviations, technical reports, change controls, for DA operations.
    • Network with global and other DA sites to understand best practices, share knowledge.
    • Work cross-functionally with the area process teams/flow team for metrics reviews, operational support, and issue/deviation management.
    • Set area human resource and business plan goals.
    • Participate in tactical and strategic business planning.
    • Communicate on project and production status.