- Plan, coordinate, conduct and conduct audits for assigned projects / process / vendor / system per BI QM auditing annual program and standards, applicable regulations and guidelines within assigned area
- If for GCP: Develop and implement the Trial Audit Plan for assigned projects; Provide Trial Audit Summary reports for assigned trials; closely monitor the risks within the assigned projects / Therapeutic area and adjust trial / project audit plan accordingly
- If for all: Audit plan, reports are issued according to BI standards
- (If applicable) Overseas the audits outsourced to the external auditor (freelance or vendor) as per BI auditing vendor oversight standards
- Information of audits required
- Scheduling of audits
- Other oversight activities as required
- (If applicable) When assigned as lead auditor, liaise closely with function to develop proper audit scope to ensure that the scope addresses risk concerns the function has related to quality and contribute to continuous improvement
- Liaise closely with compliance team in development of auditing responses by providing internal consultancy based on knowledge of regulations/guidelines, best practices within BI and industry; Review and accept CAPAs
- Active participation in QM, QM Auditing working groups and projects as assigned, contribute with knowledge of regulations / guidelines, best practices
- Provide internal constancy on relevant regulations / guidelines, best practices to functions within Medicine if required; constancy / involvement in continuous improvement initiatives at global / regional / R/OPU level as appropriate
- (If applicable) Liaise with various Medicine & RA clients and stakeholders in conjunction with QM-M&R as appropriate to identify areas of greatest compliance risk and to obtain input regarding audit program (e.g. sites, vendors, and systems). Acts as resource to others.
- Bachelor's degree or equivalent, from an accredited institution, in scientific or health related field. Advanced academic qualification or degree from an accredited institution is preferred. Equivalent relevant professional experience will be considered.
- Comprehensive knowledge and GCP or GxP experience in the pharmaceutical industry that is relevant to the area(s) of responsible auditing
- Minimum of ten (10) years pharmaceutical industry experience.
- Eight plus (8+) years GxP auditing experience with a minimum of six plus (6+) years specific experience in conducting QA GCP audits of clinical investigators, vendors, systems or documents ( if GCP auditing), or three plus (3+) years specific experience in conducting PV, medical affairs, regulatory affairs auditing; or three plus (3+) year experience in compliance management with relevant functional area
- A broad range of auditing experience/demonstrated experience in a senior advisory role.
- Extensive knowledge of regulatory requirements in the responsible area of auditing (GCP / PV/ MA/ regulatory affairs)
- International business experience
- Ability to operate independently of functional groups and provide critical independent assessments and guidance to senior management.
- Broad knowledge of requirements surrounding validation of computerized systems (specifically 21 CFR Part 11), if applicable.
- Prior experience in vendor oversight will be an advantage
- Ability to communicate clearly and effectively in writing and verbally, demonstrate excellent interpersonal skills, lead and work well in teams or independently
- Possess the ability to influence and negotiate with excellent judgment and decision making qualities, and able to multi task and manage time efficiently and effectively.
- Strong organizational and prioritization skills, good analytical and problem solving skills.
Desired Skills, Experience and Abilities:
- Mastery of other languages (in addition to English, e.g. Spanish, Chinese) is desirable.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.