What are the responsibilities and job description for the Director - Product Quality position at BioSpace?
About The Department
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The Position
Oversee the CMC QA Organization for the site, which includes responsibility for the Quality Assurance (QA) function and serves as the leading expert in quality, compliance, and quality management systems (QMS). Provide direction & coordinate the Quality organization activities to support the business progress. Formulate, communicate and implement the QA strategy that supports the manufacturing and testing of clinical products at CMO partners. Plan and execute qualification and operational readiness initiatives required to support clinical API internal manufacturing. Coordinate with leadership team & other relevant stakeholders to ensure strong communication & aligned priorities on short/medium/long range.
Relationships
Reports to Corporate Vice President.
Essential Functions
Serve as key partner for site leadership, managing business integration & site strategy to support manufacturing of clinical product through testing and quality programs to ensure product safety and quality
Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization
Participate as a member of Quality Leadership Team in setting quality goals, objectives & policies, which includes ensuring the quality goals align to the respective site’s goals
Meet or exceed business, regulatory & internal customer requirements in accordance with Novo Nordisk Way
Provide expertise on Good Manufacturing Practice compliance
Ensure technical training & development on Quality Management is in place across the site
Direct, coach & manage site quality management team, which includes but is not limited to training & development, performance management/review & development planning, talent recruitment/selection, managing employee relations, overseeing financial matters and driving continuous process improvement & projects
Maintain effective communication, collaboration & alignment across stakeholders, site management & global partners
Ensures coordination and oversight of internal audits and external inspections of CMOs
Follow all safety & environmental requirements in the performance of duties
Other accountabilities, as assigned
Physical Requirements
Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).
Development Of People
Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
Bachelor’s degree in science, engineering, business, or relevant field of study from an accredited university required, with a minimum of ten (10) years of experience in pharmaceutical quality, active pharmaceutical ingredient (API) industry, manufacturing or a related area required
Master’s degree in science, engineering or business field preferred
Minimum of five (5) years managing other managers required
Excellent working knowledge of GMP regulations relevant to the business required
Knowledgeable in systems within pharmaceutical industries to include parenteral drug production and/or Active Pharmaceutical Ingredient (API) preferred
Proven expertise in mentoring/development required
Excellent written & verbal communication skills required
Strong presentation skills required
Proven expertise in mentoring/development, process confirmation, change management, planning/organizing & managing execution required
Demonstrated ability to review complex organizational plans & provide any required or necessary guidance to ensure success required
Proven process improvement & problem-solving skills required
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
The base compensation range for this position is $181,670 to $317,920. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The Position
Oversee the CMC QA Organization for the site, which includes responsibility for the Quality Assurance (QA) function and serves as the leading expert in quality, compliance, and quality management systems (QMS). Provide direction & coordinate the Quality organization activities to support the business progress. Formulate, communicate and implement the QA strategy that supports the manufacturing and testing of clinical products at CMO partners. Plan and execute qualification and operational readiness initiatives required to support clinical API internal manufacturing. Coordinate with leadership team & other relevant stakeholders to ensure strong communication & aligned priorities on short/medium/long range.
Relationships
Reports to Corporate Vice President.
Essential Functions
Serve as key partner for site leadership, managing business integration & site strategy to support manufacturing of clinical product through testing and quality programs to ensure product safety and quality
Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization
Participate as a member of Quality Leadership Team in setting quality goals, objectives & policies, which includes ensuring the quality goals align to the respective site’s goals
Meet or exceed business, regulatory & internal customer requirements in accordance with Novo Nordisk Way
Provide expertise on Good Manufacturing Practice compliance
Ensure technical training & development on Quality Management is in place across the site
Direct, coach & manage site quality management team, which includes but is not limited to training & development, performance management/review & development planning, talent recruitment/selection, managing employee relations, overseeing financial matters and driving continuous process improvement & projects
Maintain effective communication, collaboration & alignment across stakeholders, site management & global partners
Ensures coordination and oversight of internal audits and external inspections of CMOs
Follow all safety & environmental requirements in the performance of duties
Other accountabilities, as assigned
Physical Requirements
Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).
Development Of People
Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
Bachelor’s degree in science, engineering, business, or relevant field of study from an accredited university required, with a minimum of ten (10) years of experience in pharmaceutical quality, active pharmaceutical ingredient (API) industry, manufacturing or a related area required
Master’s degree in science, engineering or business field preferred
Minimum of five (5) years managing other managers required
Excellent working knowledge of GMP regulations relevant to the business required
Knowledgeable in systems within pharmaceutical industries to include parenteral drug production and/or Active Pharmaceutical Ingredient (API) preferred
Proven expertise in mentoring/development required
Excellent written & verbal communication skills required
Strong presentation skills required
Proven expertise in mentoring/development, process confirmation, change management, planning/organizing & managing execution required
Demonstrated ability to review complex organizational plans & provide any required or necessary guidance to ensure success required
Proven process improvement & problem-solving skills required
Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
The base compensation range for this position is $181,670 to $317,920. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Salary : $181,670 - $317,920
