Senior Manager, Quality Operations

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections with real content. Must not repeat job title. Must not include Job ID etc. Must remove boilerplate like EEO, etc. Must preserve substantive info. We need to parse the posting. Key info: - About the role: description of team, role, reporting, location, hybrid schedule, expectation at least four days in office. - Responsibilities: list of primary responsibilities (bulleted). Many bullet points. - Requirements: maybe "Other Requirements" list: Experience auditing or holds auditor certification, Experience in overseeing CMO operations, Combination device experience, Demonstrated management skills..., Level Of Education Required Bachelor’s degree required..., Number of Years of Experience... Minimum of 10+ years... - Qualifications: maybe "Primary skills and knowledge required" includes leadership experience, ability to delegate, inspection readiness, GMP experience, background managing QA Ops, experience with implementing Quality On The Floor, knowledge of ERP/MES, analytical skills, self-reliant, flexible, track record, etc. - Skills: maybe overlapping with qualifications. But we can separate: Skills could be "Primary skills and knowledge required". Qualifications could be education and years of experience. However the instruction says use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what content goes where. We have content: - About the role: description of team, role, reporting, location, hybrid schedule. - Responsibilities: list of primary responsibilities (the bullet list after "Primary responsibilities include, but are not limited to, the following:"). - Requirements: maybe "Other Requirements" list (auditor certification, CMO oversight, combination device experience, management skills). Also "Level Of Education Required" and "Number of Years of Experience". Those could be under Qualifications. - Qualifications: education (Bachelor's required, master's a plus) and years of experience (10+ years). Could also include "Other Requirements" but we can treat them as Requirements. - Skills: "Primary skills and knowledge required" list (leadership experience, ability to delegate, inspection readiness, GMP experience, background managing QA Ops, experience with implementing Quality On The Floor, knowledge of ERP/MES, analytical skills, self-reliant, flexible, track record, etc.) - Benefits: Not explicitly mentioned besides hybrid schedule? There's "We offer a hybrid work schedule." That's schedule, not benefits. No explicit benefits like health, retirement. So we should not create Benefits section unless posting actually states them. It does not. So omit Benefits. - Pay: Salary range given: $142,140 - $179,220USD. Also mention "The salary offer is commensurate..." but we should not include filler like "commensurate with experience". We can include the salary range as Pay section. - Schedule: "We offer a hybrid work schedule. The expectation will be at least four days in the office but could be more at times as we approach upcoming critical milestones." So we can put Schedule section. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Pay, Schedule. We must not include empty sections. Now format: Use

for each section heading. Under each, use

for prose,

• for lists. We need to preserve all substantive information, not invent or summarize away detail. Must not omit details. We need to be careful to not include boilerplate like EEO, equal opportunity, etc. Also remove duplicated lines. Let's extract each piece. About the role: "The Quality team at EyePoint ensures that the highest standards of product quality, safety, and regulatory compliance are upheld across all initiatives. This team implements rigorous quality systems and continuous improvement practices to safeguard product integrity and support patient-focused innovation for serious retinal diseases. The Sr. Manager, Quality Operations will report to the Senior Director Global Quality Assurance and be responsible for global GMP quality within our internal and external manufacturing operations for development and commercial programs. This position will lead the Quality Operations team who provide daily operational quality support. This is an in-person role based at our Northbridge facility. We offer a hybrid work schedule. The expectation will be at least four days in the office but could be more at times as we approach upcoming critical milestones." We can keep that as prose. Responsibilities: list after "Primary responsibilities include, but are not limited to, the following:" then bullet points. Let's capture each bullet: - Individual Responsibilities Builds, develops and leads the site quality operations team from process validation (PPQ) into commercial drug product manufacturing. - Manage activities related to incoming material release, batch record review, QC testing, lot disposition, Quality Event Management, Annual Product Report reconciliation, and quality oversight at our Northbridge location. - Collaborate with Quality and Manufacturing Leadership to gain insight into organizational goals, priorities, and requirements. - Develop and communicate goals and priorities for the team that correlate to and support the organizational and corporate goals. - Implement and maintain quality systems, policies and procedures that ensure compliance to cGMP, FDA (i.e. 21CFR11, 820, 210, 211) and other regulatory standards. - Oversight and performance of manufacturing batch production record review and approval in support of product release/disposition in accordance with specifications and procedures. - Oversight and performance of test record data review and approval in support of stability testing and laboratory testing in accordance with specifications and procedures. - Supports and assists with Quality Systems-related training, including compliance with cGMP and SOPs. - Interfaces with quality, CMC, manufacturing, and supply chain personnel from external parties (e.g., CMOs or CTOs). - Provides QA review/approval of cGMP documents generated across the organization which includes, but is not limited to: SOPs, technical reports, validation documents, risk assessments, manufacturing records, APQRs, audit documents, change control, deviation & CAPAs. - Participates in mock and regulatory inspections - Actively engages in the training of staff with lesser experience or knowledge of quality operations processes. - Educates and instructs QA and plant personnel in quality best practices for sampling, labeling, good documentation practices, equipment sanitation. - Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed. - Routinely provides input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance. - Participate in a range of on-going projects and team initiatives. - Serve as the Quality Lead on product development teams in collaboration with Quality Engineering. - Expert knowledge and experience in leading teams in root cause analysis determination - Other duties as assigned We need to keep each as
• . Some sentences are long; keep them. Requirements: "Other Requirements" list: - Experience auditing or holds auditor certification - Experience in overseeing CMO operations - Combination device experience - Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development Also maybe "Level Of Education Required Bachelor’s degree required (Scientific discipline, or other technical disciplines); master's degree a plus" and "Number of Years of Experience in the Function and in the Industry: Minimum of 10+ years of related experience in the pharmaceutical or biotechnology industry, preferably in pharmaceutical development and Quality Assurance Operations". Those could be under Qualifications. But we need to decide: Requirements vs Qualifications. The instruction says use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we need to allocate content accordingly. We can treat: - Requirements: the "Other Requirements" list (auditor certification, CMO oversight, combination device experience, management skills). Also maybe "Level Of Education Required" and "Years of Experience" could be under Qualifications. - Qualifications: education and years of experience. - Skills: "Primary skills and knowledge required" list. Let's extract Skills list: "This position has direct supervisory responsibilities of the Northbridge Site Quality Assurance Operations team. Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources. Ability to delegate or review, approve and critique protocols and reports of equipment and pharmaceutical combination products. Experience with inspection readiness initiatives and in involvement with PAI inspections. Demonstrated strong GMP experience with an understanding of all aspects of technical development and manufacturing from product development through commercialization, including validation. Strong background and demonstrated effectiveness in managing Quality Assurance Operations and compliance of commercial combination products in an FDA regulated environment. Experience with implementing and managing Quality On The Floor process. Knowledge of electronic manufacturing support systems including any of the following: ERP and MES highly desirable Strong analytical, problem solving, and decision-making skills. Self-reliant in meeting goals and objectives. Flexible and able to respond quickly to shifting priorities and meet deadlines. Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment." We need to keep each as
• . Now Pay: Salary range: "$142,140 - $179,220USD". Also maybe mention "The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity." But that is filler-ish; we should not include "commensurate with experience" etc. The instruction says: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. The posting does state salary range, so we can include Pay section with the range. The sentence about commensurate is filler; we should omit it. So Pay section just includes the salary range. Schedule: "We offer a hybrid work schedule. The expectation will be at least four days in the office but could be more at times as we approach upcoming critical milestones." Now we need to output HTML fragment only. Let's craft:

  About the role

  ...

  Responsibilities

  • ...
  ...

  Requirements

  • Experience auditing or holds auditor certification
  • Experience in overseeing CMO operations
  • Combination device experience
  • Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development

  Qualifications

  • Bachelor’s degree required (Scientific discipline, or other technical disciplines); master's degree a plus
  • Minimum of 10+ years of related experience in the pharmaceutical or biotechnology industry, preferably in pharmaceutical development and Quality Assurance Operations

  Skills

  • This position has direct supervisory responsibilities of the Northbridge Site Quality Assurance Operations team.
  • Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources.
  • Ability to delegate or review, approve and critique protocols and reports of equipment and pharmaceutical combination products.
  • Experience with inspection readiness initiatives and in involvement with PAI inspections.
  • Demonstrated strong GMP experience with an understanding of all aspects of technical development and manufacturing from product development through commercialization, including validation.
  • Strong background and demonstrated effectiveness in managing Quality Assurance Operations and compliance of commercial combination products in an FDA regulated environment.
  • Experience with implementing and managing Quality On The Floor process.
  • Knowledge of electronic manufacturing support systems including any of the following: ERP and MES highly desirable
  • Strong analytical, problem solving, and decision-making skills.
  • Self-reliant in meeting goals and objectives.
  • Flexible and able to respond quickly to shifting priorities and meet deadlines.
  • Track record of strong personal performance combined