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Associate Director, Quality Operations
$129k-157k (estimate)
Full Time | Ancillary Healthcare
1 Week Ago
Stoke Therapeutics Inc is Hiring an Associate Director, Quality Operations Near Cambridge, MA
About Stoke:Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:The Associate Director, GMP Quality Operations will be the primary quality contact for quality oversight of GMP operations performed at Stoke’s CMOs and CTLs regarding process tech-transfer, scale-up, process validation and manufacture and of Stoke IMPs. This person will lead initiatives for the Quality relationship and partnership collaboration with CMOs to deliver product compliant with cGMPs, regulations (e.g., FDA, EMA, etc.) and Stoke requirements. This person will also be a key contributor to maturing and shaping Stoke’s internal GMP quality processes and Stoke’s eQMS in the areas of change management and deviations / CAPA management. This candidate shall have a demonstrated ability to translate operational strategy into action with excellent analytical skills and an ability to communicate complex issues clearly to a broad group of people. This person should have experience in orchestrating plans to resolve issues and mitigate risks in a timely manner to ensure uninterrupted supply. This candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This role will report to the VP of Quality and will interface closely with other cross-functional groups such as CMC Manufacturing & Analytical Development, Supply Chain, Regulatory CMC and other functions within Quality.
The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working with CMOs and CTLs. It is preferred that this candidate have prior experience working with external vendors and in participating directly and indirectly in regulatory inspections. It is also preferred that this candidate has direct working knowledge of unit operations as it relates to Oligonucleotide Drug Substance manufacturing or Sterile Fill Finish or Clinical Packaging and Distribution. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required.
Key Responsibilities:
Travel:This position will require approximately 20% travel.
Culture & Values:At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:The Associate Director, GMP Quality Operations will be the primary quality contact for quality oversight of GMP operations performed at Stoke’s CMOs and CTLs regarding process tech-transfer, scale-up, process validation and manufacture and of Stoke IMPs. This person will lead initiatives for the Quality relationship and partnership collaboration with CMOs to deliver product compliant with cGMPs, regulations (e.g., FDA, EMA, etc.) and Stoke requirements. This person will also be a key contributor to maturing and shaping Stoke’s internal GMP quality processes and Stoke’s eQMS in the areas of change management and deviations / CAPA management. This candidate shall have a demonstrated ability to translate operational strategy into action with excellent analytical skills and an ability to communicate complex issues clearly to a broad group of people. This person should have experience in orchestrating plans to resolve issues and mitigate risks in a timely manner to ensure uninterrupted supply. This candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This role will report to the VP of Quality and will interface closely with other cross-functional groups such as CMC Manufacturing & Analytical Development, Supply Chain, Regulatory CMC and other functions within Quality.
The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working with CMOs and CTLs. It is preferred that this candidate have prior experience working with external vendors and in participating directly and indirectly in regulatory inspections. It is also preferred that this candidate has direct working knowledge of unit operations as it relates to Oligonucleotide Drug Substance manufacturing or Sterile Fill Finish or Clinical Packaging and Distribution. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for quality management is essential to this role. The candidate should be willing to directly contribute to the improvement of processes and resolution of issues as required.
Key Responsibilities:
- Establish and maintain SOPs for GMPs to meet ICH, FDA, and EMA regulations.
- Oversight and day-to-day management of outsourced GMP operations at various CMOs to support the successful and compliant execution of GMP operations to meet regulatory requirements, guidelines, internal policies, and procedures.
- Review and approve documentation generated at CMOs, including master batch records, specifications, deviations and investigations, process validation protocols/reports and change controls.
- Final batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigations.
- Compile necessary data and analyze metrics for compliance health checks for External Quality Business Review Meetings and Quality Management Review.
- Represent quality on project teams, as needed and provide GMP compliance. interpretation, consultation, and other supportive services necessary to maintain and improve compliance to ensure product quality, data integrity and patient safety.
- Support external GMP vendor audits, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
- Support GMP regulatory inspections as SME, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections.
- Interact with Stoke QPs to process forward required documents for importation, third party declaration and batch certification of product designated for the UK and the EU.
- Provide GMP compliance technical support during regulatory inspections at Stoke’s CMOs as necessary.
- Provide QA input/review during the submission of regulatory filings.
- Contribute to the development of Stoke’s Quality culture.
- BS/BA, MS in life sciences or chemistry with a minimum of 10 years’ experience in Biotech or Pharma setting with direct experience in GMP Operations as it relates to either Oligonucleotide Drug Substance manufacturing, sterile fill finish operations and clinical packaging.
- Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and implementing GMPs in a practical manner.
- Experience in managing CMOs.
- Attention to detail with the ability to work within a multi-disciplinary team, as well as with external partners and vendors to establish strong and maintain a strong quality relationship.
- Experience with drug substance and/or drug product (both preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting.
- Ability to work autonomously, provide QA/QC advice, effectively manage time, and deliver results on time.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Experience in reviewing submission documentation.
- Experience in process validation for commercial product development.
- Proficient in using Veeva eQMS and Veeva Vault Quality.
- Prior experience in participating in regulatory inspections and responding to regulatory response.
- Ability to manage multiple projects in a fast-paced environment.
- Excellent organizational, interpersonal, verbal, and written communication skills.
- Conflict resolution/management and negotiation skills.
Travel:This position will require approximately 20% travel.
Culture & Values:At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Ancillary Healthcare
SALARY
$129k-157k (estimate)
POST DATE
06/21/2024
EXPIRATION DATE
07/13/2024
WEBSITE
stoketherapeutics.com
HEADQUARTERS
BEDFORD, MA
SIZE
50 - 100
FOUNDED
2017
TYPE
Public
CEO
EDWARD M KAYE
REVENUE
$5M - $10M
INDUSTRY
Ancillary Healthcare
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About Stoke Therapeutics Inc
Stoke Therapeutics focuses on developing antisense oligonucleotide medicines for the treatment of genetic diseases.
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The job skills required for Associate Director, Quality Operations include Initiative, Collaboration, Innovation, Quality Management, Written Communication, Supply Chain, etc. Having related job skills and expertise will give you an advantage when applying to be an Associate Director, Quality Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Associate Director, Quality Operations. Select any job title you are interested in and start to search job requirements.
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