Job description

Senior Operations QA Manager – Clinical (Core)

SUMMARY/JOB PURPOSE:

The Senior Manager, Operations QA - Clinical is accountable for the QA oversight of day-to-day end-to-end (Drug Substance, Drug product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, managing product complaints.

Assists in the management of Exelixis partnerships, collaborations. audits , and forges strong relationships.

Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

As QA Core, support QA Partner

Maintain and continuously improve QA programs, policies and procedures to ensure GMP compliance of clinical trial material.
Perform record review, batch disposition for clinical trial material.
Oversee CMOs: Deviations, CAPAs, rapidly escalate and resolve issues.
Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, etc.)
Maintain and report CMO metrics and QA metrics.
Identify and rapidly mitigate risk.
Contribute to APQR (annual product quality review) as applicable.
Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs.
Evaluate and generate data to support KPIs (Key Performance Indicators)
Understands regulatory requirements.
Deliver per supply plans, drive results.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or,
Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or,
PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or,
Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred
Two years’ experience managing Contract Manufacturing Organizations preferred
Five years general experience in biotech/pharmaceutical industry.
Experience in development of metrics and continuous improvements is preferred

Knowledge/Skills:

Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines.
Proven experience in a virtual manufacturing environment or relevant industry/profession.
Small molecule, oral solid form, biologics technical knowledge required.
Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways.
Implements technical solutions within quality requirements to complex problems.
Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
Great attention to detail.
Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics
Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization.
Excellent MS Office, Word, Excel and PowerPoint skills.

JOB COMPLEXITY:

WORKING CONDITIONS:

Travel as required

#LI-EZ1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $140,000 - $199,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Alameda, CA

Posted 40 days ago

Product Development

Full time Regular

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SUMMARY/JOB PURPOSE:

The Senior Manager, Operations QA - Clinical is accountable for the QA oversight of day-to-day end-to-end (Drug Substance, Drug product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, managing product complaints.

Assists in the management of Exelixis partnerships, collaborations. audits , and forges strong relationships.

Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

As QA Core, support QA Partner

Maintain and continuously improve QA programs, policies and procedures to ensure GMP compliance of clinical trial material.
Perform record review, batch disposition for clinical trial material.
Oversee CMOs: Deviations, CAPAs, rapidly escalate and resolve issues.
Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, etc.)
Maintain and report CMO metrics and QA metrics.
Identify and rapidly mitigate risk.
Contribute to APQR (annual product quality review) as applicable.
Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs.
Evaluate and generate data to support KPIs (Key Performance Indicators)
Understands regulatory requirements.
Deliver per supply plans, drive results.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or,
Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or,
PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or,
Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred
Two years’ experience managing Contract Manufacturing Organizations preferred
Five years general experience in biotech/pharmaceutical industry.
Experience in development of metrics and continuous improvements is preferred

Knowledge/Skills:

Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines.
Proven experience in a virtual manufacturing environment or relevant industry/profession.
Small molecule, oral solid form, biologics technical knowledge required.
Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways.
Implements technical solutions within quality requirements to complex problems.
Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
Great attention to detail.
Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics
Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization.
Excellent MS Office, Word, Excel and PowerPoint skills.

JOB COMPLEXITY:

WORKING CONDITIONS:

Travel as required

#LI-EZ1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $140,000 - $199,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.